Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years (NCT NCT04895982)
NCT ID: NCT04895982
Last Updated: 2024-10-09
Results Overview
GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
1 Month after Vaccination 3
Results posted on
2024-10-09
Participant Flow
A total of 124 participants were enrolled in this study.
Participant milestones
| Measure |
(Greater Than or Equal to (>=) 2 to Less Than (<) 5 Years With Immunomodulatory Therapy
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged \>=5 to \<12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Solid Organ Transplant
Participants aged \>=5 to \<12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Stem Cell Transplant
Participants aged \>=5 to \<12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged \>=12 to \<18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Solid Organ Transplant
Participants aged \>=12 to \<18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Stem Cell Transplant
Participants aged \>=12 to \<18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Immunomodulatory Therapy
Participants aged \>=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
13
|
19
|
24
|
22
|
7
|
1
|
7
|
5
|
1
|
1
|
|
Overall Study
Dose 1
|
9
|
15
|
13
|
19
|
24
|
22
|
7
|
1
|
7
|
5
|
1
|
1
|
|
Overall Study
Dose 2
|
9
|
15
|
12
|
19
|
24
|
22
|
7
|
1
|
7
|
5
|
1
|
1
|
|
Overall Study
Dose 3
|
9
|
15
|
11
|
17
|
24
|
22
|
7
|
1
|
6
|
5
|
1
|
1
|
|
Overall Study
Dose 4
|
7
|
13
|
6
|
14
|
20
|
17
|
5
|
1
|
3
|
3
|
1
|
0
|
|
Overall Study
COMPLETED
|
7
|
12
|
6
|
16
|
20
|
18
|
5
|
0
|
3
|
3
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
7
|
3
|
4
|
4
|
2
|
1
|
4
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
(Greater Than or Equal to (>=) 2 to Less Than (<) 5 Years With Immunomodulatory Therapy
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged \>=5 to \<12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Solid Organ Transplant
Participants aged \>=5 to \<12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Stem Cell Transplant
Participants aged \>=5 to \<12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged \>=12 to \<18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Solid Organ Transplant
Participants aged \>=12 to \<18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Stem Cell Transplant
Participants aged \>=12 to \<18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Immunomodulatory Therapy
Participants aged \>=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by parent/guardian
|
2
|
3
|
3
|
1
|
3
|
2
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Refused further study procedures
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
Baseline characteristics by cohort
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=5 to \<12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=5 to \<12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=5 to \<12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=12 to \<18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=12 to \<18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=12 to \<18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Non-Small Cell Lung Cancer
n=1 Participants
Participants with non-small cell lung cancer aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>= 18 Years With Haemodialysis
n=1 Participants
Participants undergone maintenance haemodialysis treatment aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
51 Participants
n=36 Participants
|
|
Age, Customized
Children (2-11 years)
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
102 Participants
n=36 Participants
|
|
Age, Customized
Adolescents (12-17 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
|
7 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
|
Age, Customized
Adults (18-64 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Age, Customized
From 65-84 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Age, Customized
Not disclosed
|
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
70 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Not disclosed
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
98 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
103 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 3Population: Dose 3 EIP= all participants who received 3 doses of vaccine with Dose 2 and Dose 3 within predefined window, had at least 1 valid \& determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 3); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 3 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 3 in '\>=2 to \<5 years with stem cell transplant' arm.
GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
600.2 Titers
Interval 77.8 to 4629.8
|
884.7 Titers
Interval 176.7 to 4430.6
|
—
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 3Population: Dose 3 EIP= all randomized participants who received 3 doses of vaccine with Dose 2 and Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 3), and had no other important protocol deviations as determined by the clinician.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=6 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=9 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=11 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
758.4 Titers
Interval 123.7 to 4650.4
|
741.2 Titers
Interval 150.6 to 3647.0
|
4592.3 Titers
Interval 1989.5 to 10600.4
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 3Population: Dose 3 EIP= all randomized participants who received 3 doses of vaccine with Dose 2 and Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 3), and had no other important protocol deviations as determined by the clinician.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=1 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=2 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
7330.0 Titers
95% CI could not be calculated as only one participant was analyzed.
|
43.5 Titers
95% CI could not be calculated as only one participant was analyzed.
|
2368.1 Titers
Interval 1679.9 to 3338.3
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 3Population: Dose 3 EIP= all participants who received 3 doses of vaccine with Dose 2 and Dose 3 within predefined window, had at least 1 valid \& determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 3); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 3 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 3 in '\>=18 years with non small cell lung cancer' arm.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=2 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
596.5 Titers
Interval 0.1 to 3699753.4
|
—
|
115.0 Titers
95% CI could not be calculated as only one participant was analyzed.
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 4Population: Dose 4 EIP= all participants who received 4 doses of vaccine with Dose 2,3\&4 within predefined window,had at least 1 valid \& determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 4); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 4 in '\>=2 to \<5 years with stem cell transplant' arm.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=3 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=2 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
837.5 Titers
Interval 1.4 to 518774.5
|
9576.3 Titers
Interval 0.0 to 2070132632.7
|
—
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 4Population: Dose 4 EIP= all randomized participants who received 4 doses of vaccine with Dose 2, Dose 3 and Dose 4 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 4), and had no other important protocol deviations as determined by the clinician.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=2 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=4 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=2 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
754.2 Titers
Interval 0.0 to 351878145.2
|
5335.3 Titers
Interval 517.0 to 55061.8
|
5330.8 Titers
Interval 0.0 to 113927797661576.0
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 4Population: Dose 4 EIP=all participants who received 4 doses of vaccine with Dose 2,3\&4 within predefined window,had atleast 1 valid\&determinate immunogenicity result from sample collected within appropriate window(28-42 days,inclusive,after Dose4);had no other important protocol deviations as determined by clinician.No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose4 in'12 to \<18 years with immunomodulatory therapy\&stem cell transplant'arm.
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
—
|
2845.0 Titers
95% CI could not be calculated as only one participant was analyzed.
|
—
|
PRIMARY outcome
Timeframe: 1 Month after Vaccination 4Population: Dose 4 EIP=all participants who received 4 doses of vaccine with Dose 2,3\&4 within predefined window,had at least 1 valid\& determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 4); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 4 in '\>=18 years with non-small cell lung cancer\&hemodialysis'
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP .
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=1 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
|
1474.0 Titers
95% CI could not be calculated as only one participant was analyzed.
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in an electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\>0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Redness: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Redness: Mild
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Swelling: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Pain at the injection site: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
23.1 Percentage of participants
95% Confidence Interval 5.0 • Interval 5.0 to 53.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Pain at the injection site: Mild
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
23.1 Percentage of participants
95% Confidence Interval 5.0 • Interval 5.0 to 53.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Pain at the injection site: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Pain at the injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Pain at the injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Redness: Any
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Redness: Mild
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Swelling: Any
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
18.2 Percentage of participants
95% Confidence Interval 5.2 • Interval 5.2 to 40.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Swelling: Mild
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Pain at the injection site: Any
|
73.7 Percentage of participants
95% Confidence Interval 48.8 • Interval 48.8 to 90.9
|
58.3 Percentage of participants
95% Confidence Interval 36.6 • Interval 36.6 to 77.9
|
54.5 Percentage of participants
95% Confidence Interval 32.2 • Interval 32.2 to 75.6
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Pain at the injection site: Mild
|
52.6 Percentage of participants
95% Confidence Interval 28.9 • Interval 28.9 to 75.6
|
50.0 Percentage of participants
95% Confidence Interval 29.1 • Interval 29.1 to 70.9
|
45.5 Percentage of participants
95% Confidence Interval 24.4 • Interval 24.4 to 67.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Pain at the injection site: Moderate
|
21.1 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 45.6
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Pain at the injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Pain at the injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Redness: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Redness: Mild
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Swelling: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Swelling: Moderate
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Pain at the injection site: Any
|
85.7 Percentage of participants
95% Confidence Interval 42.1 • Interval 42.1 to 99.6
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
57.1 Percentage of participants
95% Confidence Interval 18.4 • Interval 18.4 to 90.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Pain at the injection site: Mild
|
71.4 Percentage of participants
95% Confidence Interval 29.0 • Interval 29.0 to 96.3
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Pain at the injection site: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Pain at the injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Pain at the injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Redness: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Redness: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Swelling: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Pain at injection site: Any
|
80.0 Percentage of participants
95% Confidence Interval 28.4 • Interval 28.4 to 99.5
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Pain at injection site: Mild
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Pain at injection site: Moderate
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows
Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate(\>2.0 to 7.0 cm), severe(\>7.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis\[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=11 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Redness: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Redness: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Swelling: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Pain at injection site: Any
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Pain at injection site: Mild
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Pain at injection site: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 28.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Swelling: Any
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
31.8 Percentage of participants
95% Confidence Interval 13.9 • Interval 13.9 to 54.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Redness: Any
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
22.7 Percentage of participants
95% Confidence Interval 7.8 • Interval 7.8 to 45.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Redness: Mild
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Swelling: Mild
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
22.7 Percentage of participants
95% Confidence Interval 7.8 • Interval 7.8 to 45.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Pain at injection site: Any
|
68.4 Percentage of participants
95% Confidence Interval 43.4 • Interval 43.4 to 87.4
|
62.5 Percentage of participants
95% Confidence Interval 40.6 • Interval 40.6 to 81.2
|
50.0 Percentage of participants
95% Confidence Interval 28.2 • Interval 28.2 to 71.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Pain at injection site: Mild
|
52.6 Percentage of participants
95% Confidence Interval 28.9 • Interval 28.9 to 75.6
|
45.8 Percentage of participants
95% Confidence Interval 25.6 • Interval 25.6 to 67.2
|
22.7 Percentage of participants
95% Confidence Interval 7.8 • Interval 7.8 to 45.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Pain at injection site: Moderate
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
16.7 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 37.4
|
27.3 Percentage of participants
95% Confidence Interval 10.7 • Interval 10.7 to 50.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention. 'Number Analyzed (n)' signifies participants evaluable for specified rows.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Redness: Any
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Redness: Mild
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Swelling: Any
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Swelling: Moderate
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Pain at injection site: Any
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
57.1 Percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Pain at injection site: Mild
|
57.1 Percentage of participants
Interval 18.4 to 90.1
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Pain at injection site: Moderate
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Redness: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Redness: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Swelling: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Pain at injection site: Any
|
80.0 Percentage of participants
95% Confidence Interval 28.4 • Interval 28.4 to 99.5
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Pain at injection site: Mild
|
60.0 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Pain at injection site: Moderate
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=11 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Redness: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Redness: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Redness: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Swelling: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Swelling: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Pain at injection site: Any
|
22.2 Percentage of participants
95% Confidence Interval 2.8 • Interval 2.8 to 60.0
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
9.1 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 41.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Pain at injection site: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
9.1 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 41.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Pain at injection site: Moderate
|
22.2 Percentage of participants
95% Confidence Interval 2.8 • Interval 2.8 to 60.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=17 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=23 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=21 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Redness: Any
|
29.4 Percentage of participants
95% Confidence Interval 10.3 • Interval 10.3 to 56.0
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
14.3 Percentage of participants
95% Confidence Interval 3.0 • Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Redness: Mild
|
17.6 Percentage of participants
95% Confidence Interval 3.8 • Interval 3.8 to 43.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
9.5 Percentage of participants
95% Confidence Interval 1.2 • Interval 1.2 to 30.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Redness: Moderate
|
11.8 Percentage of participants
95% Confidence Interval 1.5 • Interval 1.5 to 36.4
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
4.8 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Swelling: Any
|
17.6 Percentage of participants
95% Confidence Interval 3.8 • Interval 3.8 to 43.4
|
8.7 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 28.0
|
14.3 Percentage of participants
95% Confidence Interval 3.0 • Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Swelling: Mild
|
5.9 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 28.7
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
9.5 Percentage of participants
95% Confidence Interval 1.2 • Interval 1.2 to 30.4
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Swelling: Moderate
|
11.8 Percentage of participants
95% Confidence Interval 1.5 • Interval 1.5 to 36.4
|
8.7 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 28.0
|
4.8 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Pain at injection site: Any
|
70.6 Percentage of participants
95% Confidence Interval 44.0 • Interval 44.0 to 89.7
|
26.1 Percentage of participants
95% Confidence Interval 10.2 • Interval 10.2 to 48.4
|
57.1 Percentage of participants
95% Confidence Interval 34.0 • Interval 34.0 to 78.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Pain at injection site: Mild
|
35.3 Percentage of participants
95% Confidence Interval 14.2 • Interval 14.2 to 61.7
|
21.7 Percentage of participants
95% Confidence Interval 7.5 • Interval 7.5 to 43.7
|
42.9 Percentage of participants
95% Confidence Interval 21.8 • Interval 21.8 to 66.0
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Pain at injection site: Moderate
|
35.3 Percentage of participants
95% Confidence Interval 14.2 • Interval 14.2 to 61.7
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
14.3 Percentage of participants
95% Confidence Interval 3.0 • Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 19.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 16.1
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm), moderate(\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Redness: Any
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Redness: Mild
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Redness: Moderate
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Swelling: Any
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Swelling: Moderate
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Pain at injection site: Any
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Pain at injection site: Mild
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Pain at injection site: Moderate
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Data is not reported for "\>=18 Years with Non-Small Cell Lung Cancer" arm as e-diary data is not transmitted (i.e. participants had not reported the data for the entire e- diary collection period).
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=4 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Redness: Any
|
25.0 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Redness: Mild
|
25.0 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Swelling: Any
|
25.0 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Swelling: Mild
|
25.0 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Pain at injection site: Any
|
75.0 Percentage of participants
95% Confidence Interval 19.4 • Interval 19.4 to 99.4
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Pain at injection site: Mild
|
50.0 Percentage of participants
95% Confidence Interval 6.8 • Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Pain at injection site: Moderate
|
25.0 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Swelling: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Redness: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Redness: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Redness: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Swelling: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Pain at injection site: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Pain at injection site: Mild
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Pain at injection site: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=12 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=19 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Redness: Any
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
20.0 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 48.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Redness: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Swelling: Any
|
16.7 Percentage of participants
95% Confidence Interval 2.1 • Interval 2.1 to 48.4
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
20.0 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 48.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Swelling: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Swelling: Moderate
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Pain at injection site: Any
|
91.7 Percentage of participants
95% Confidence Interval 61.5 • Interval 61.5 to 99.8
|
42.1 Percentage of participants
95% Confidence Interval 20.3 • Interval 20.3 to 66.5
|
40.0 Percentage of participants
95% Confidence Interval 16.3 • Interval 16.3 to 67.7
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Pain at injection site: Mild
|
41.7 Percentage of participants
95% Confidence Interval 15.2 • Interval 15.2 to 72.3
|
31.6 Percentage of participants
95% Confidence Interval 12.6 • Interval 12.6 to 56.6
|
26.7 Percentage of participants
95% Confidence Interval 7.8 • Interval 7.8 to 55.1
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Pain at injection site: Moderate
|
50.0 Percentage of participants
95% Confidence Interval 21.1 • Interval 21.1 to 78.9
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention.Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=4 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=3 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Redness: Any
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
0 Percentage of participants
Interval 0.0 to 97.5
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Redness: Mild
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
0 Percentage of participants
Interval 0.0 to 97.5
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Swelling: Any
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Swelling: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Pain at injection site: Any
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Pain at injection site: Mild
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Pain at injection site: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Participants of \>=18 years haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=3 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Redness: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Redness: Mild
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Redness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Redness: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Swelling: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Swelling: Mild
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Swelling: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Swelling: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Pain at injection site: Any
|
66.7 Percentage of participants
95% Confidence Interval 9.4 • Interval 9.4 to 99.2
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Pain at injection site: Mild
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Pain at injection site: Moderate
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Pain at injection site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Pain at injection site: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 degree C (deg C); categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fatigue: Any
|
22.2 Percentage of participants
95% Confidence Interval 2.8 • Interval 2.8 to 60.0
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fatigue: Mild
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fatigue: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Headache: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Headache: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Headache: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Chills: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Chills: Mild
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Chills: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Vomiting: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
23.1 Percentage of participants
95% Confidence Interval 5.0 • Interval 5.0 to 53.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Vomiting: Mild
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
15.4 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 45.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Diarrhea: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
20.0 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 48.1
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Diarrhea: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
20.0 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 48.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 24.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fever: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
15.4 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 45.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
7.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 36.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fever: Any
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fatigue: Any
|
47.4 Percentage of participants
Interval 24.4 to 71.1
|
37.5 Percentage of participants
Interval 18.8 to 59.4
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fatigue: Mild
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fatigue: Moderate
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
9.1 Percentage of participants
Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Headache: Any
|
42.1 Percentage of participants
Interval 20.3 to 66.5
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Headache: Mild
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
9.1 Percentage of participants
Interval 1.1 to 29.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Headache: Moderate
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
0 Percentage of participants
Interval 0.0 to 14.2
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Chills: Any
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
0 Percentage of participants
Interval 0.0 to 14.2
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Chills: Mild
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Chills: Moderate
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Vomiting: Any
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Vomiting: Mild
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Diarrhea: Any
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
0 Percentage of participants
Interval 0.0 to 14.2
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Diarrhea: Mild
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
0 Percentage of participants
Interval 0.0 to 14.2
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Any
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Moderate
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Any
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Moderate
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 15.4
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fever: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fever: >=38.0 deg C to 38.4 deg C
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fatigue: Any
|
57.1 Percentage of participants
95% Confidence Interval 18.4 • Interval 18.4 to 90.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fatigue: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fatigue: Moderate
|
57.1 Percentage of participants
95% Confidence Interval 18.4 • Interval 18.4 to 90.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Headache: Any
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Headache: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Headache: Moderate
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Chills: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Chills: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Chills: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Vomiting: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Vomiting: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Diarrhea: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Diarrhea: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Any
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Moderate
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 1Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fever: Any
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fatigue: Any
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fatigue: Mild
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fatigue: Moderate
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Headache: Any
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Headache: Mild
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Headache: Moderate
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Chills: Any
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Chills: Mild
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Chills: Moderate
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Diarrhea: Any
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Diarrhea: Mild
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 52.2
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened muscle pain: Any
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
Interval 0.0 to 52.2
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened muscle pain: Moderate
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened joint pain: Any
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened joint pain: Moderate
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=10 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fever: Any
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fever: >=38.0 deg C to 38.4 deg C
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fatigue: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fatigue: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fatigue: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Headache: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Headache: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Headache: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Chills: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Chills: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Chills: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Diarrhea: Any
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Diarrhea: Mild
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Any
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 30.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Headache: Any
|
36.8 Percentage of participants
95% Confidence Interval 16.3 • Interval 16.3 to 61.6
|
29.2 Percentage of participants
95% Confidence Interval 12.6 • Interval 12.6 to 51.1
|
18.2 Percentage of participants
95% Confidence Interval 5.2 • Interval 5.2 to 40.3
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Headache: Mild
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Headache: Moderate
|
21.1 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 45.6
|
16.7 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 37.4
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Chills: Any
|
21.1 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 45.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Chills: Mild
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Chills: Moderate
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Vomiting: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Diarrhea: Any
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Diarrhea: Mild
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Any
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Moderate
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Any
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Moderate
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fever: Any
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fever: >=38.0 deg C to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fever: >38.4 deg C to 38.9 deg C
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fatigue: Any
|
57.9 Percentage of participants
95% Confidence Interval 33.5 • Interval 33.5 to 79.7
|
37.5 Percentage of participants
95% Confidence Interval 18.8 • Interval 18.8 to 59.4
|
45.5 Percentage of participants
95% Confidence Interval 24.4 • Interval 24.4 to 67.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fatigue: Mild
|
26.3 Percentage of participants
95% Confidence Interval 9.1 • Interval 9.1 to 51.2
|
20.8 Percentage of participants
95% Confidence Interval 7.1 • Interval 7.1 to 42.2
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fatigue: Moderate
|
31.6 Percentage of participants
95% Confidence Interval 12.6 • Interval 12.6 to 56.6
|
16.7 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 37.4
|
31.8 Percentage of participants
95% Confidence Interval 13.9 • Interval 13.9 to 54.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fever: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fever: >=38.0 deg C to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fever: >38.9 deg C to 40.0 deg C
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fatigue: Any
|
85.7 Percentage of participants
95% Confidence Interval 42.1 • Interval 42.1 to 99.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
33.3 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fatigue: Mild
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
33.3 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fatigue: Moderate
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fatigue: Severe
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Headache: Any
|
71.4 Percentage of participants
95% Confidence Interval 29.0 • Interval 29.0 to 96.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Headache: Mild
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Headache: Moderate
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Chills: Any
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Chills: Mild
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Chills: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Vomiting: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Vomiting: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Vomiting: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Diarrhea: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Diarrhea: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Any
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Moderate
|
42.9 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 81.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Mild
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 2Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fever: Any
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fever: >=38.0 to 38.4 deg C
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fatigue: Any
|
60.0 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fatigue: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fatigue: Moderate
|
60.0 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Headache: Any
|
60.0 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Headache: Mild
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Headache: Moderate
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Chills: Any
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Chills: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Chills: Moderate
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Vomiting: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Diarrhea: Any
|
60.0 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Diarrhea: Mild
|
40.0 Percentage of participants
95% Confidence Interval 5.3 • Interval 5.3 to 85.3
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Diarrhea: Moderate
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened muscle pain: Any
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened muscle pain: Moderate
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened joint pain: Any
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened joint pain: Moderate
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=11 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fever: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fever: >=38.0 deg C to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fatigue: Any
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fatigue: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fatigue: Moderate
|
11.1 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 48.2
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Headache: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Headache: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Headache: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Chills: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Chills: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Chills: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Vomiting: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Diarrhea: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Diarrhea: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=17 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=23 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=21 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Mild
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: Any
|
17.6 Percentage of participants
Interval 3.8 to 43.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: >=38.0 to 38.4 deg C
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fever: Unknown
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fatigue: Any
|
47.1 Percentage of participants
Interval 23.0 to 72.2
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fatigue: Mild
|
35.3 Percentage of participants
Interval 14.2 to 61.7
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fatigue: Moderate
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Headache: Any
|
35.3 Percentage of participants
Interval 14.2 to 61.7
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Headache: Mild
|
29.4 Percentage of participants
Interval 10.3 to 56.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Headache: Moderate
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Chills: Any
|
17.6 Percentage of participants
Interval 3.8 to 43.4
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Chills: Mild
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Chills: Moderate
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
9.5 Percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Diarrhea: Any
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Diarrhea: Mild
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Any
|
29.4 Percentage of participants
Interval 10.3 to 56.0
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Moderate
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Moderate
|
23.5 Percentage of participants
Interval 6.8 to 49.9
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Any
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
4.3 Percentage of participants
Interval 2.8 to 33.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 19.5
|
4.3 Percentage of participants
Interval 2.8 to 33.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fever: Any
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fever: >=38.0 to 38.4 deg C
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fever: >38.4°C to 38.9 deg C
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fever: >38.9°C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fatigue: Any
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fatigue: Mild
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fatigue: Moderate
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Headache: Any
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Headache: Mild
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Headache: Moderate
|
57.1 Percentage of participants
Interval 18.4 to 90.1
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Chills: Any
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Chills: Mild
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Chills: Moderate
|
57.1 Percentage of participants
Interval 18.4 to 90.1
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Diarrhea: Any
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Diarrhea: Mild
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Any
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Mild
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Moderate
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Any
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Moderate
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 3Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Data is not reported for "\>=18 Years with Non-Small Cell Lung Cancer" arm as e-diary data is not transmitted (i.e. participants had not reported the data for the entire e- diary collection period).
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=4 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fever:Any
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fatigue: Any
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fatigue: Mild
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fatigue: Moderate
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Headache: Any
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Headache: Mild
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Headache: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Chills: Any
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Chills: Mild
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Chills: Moderate
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Diarrhea: Any
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Diarrhea: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Diarrhea: Moderate
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened muscle pain: Any
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened muscle pain: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened joint pain: Any
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened joint pain: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Headache: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Headache: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Headache: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Chills: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Chills: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Chills: Moderate
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Vomiting: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Diarrhea: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Diarrhea: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fever: Any
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fever: >=38.0 to 38.4 deg C
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fever: >38.4 to 38.9 deg C
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fatigue: Any
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fatigue: Mild
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fatigue: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 de, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=12 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=19 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fever: Any
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fever: >38.9 to 40.0 deg C
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fatigue: Any
|
50.0 Percentage of participants
95% Confidence Interval 21.1 • Interval 21.1 to 78.9
|
26.3 Percentage of participants
95% Confidence Interval 9.1 • Interval 9.1 to 51.2
|
33.3 Percentage of participants
95% Confidence Interval 11.8 • Interval 11.8 to 61.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fatigue: Mild
|
33.3 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 65.1
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fatigue: Moderate
|
16.7 Percentage of participants
95% Confidence Interval 2.1 • Interval 2.1 to 48.4
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
20.0 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 48.1
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Headache: Any
|
33.3 Percentage of participants
95% Confidence Interval 9.9 • Interval 9.9 to 65.1
|
21.1 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 45.6
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Headache: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Headache: Moderate
|
25.0 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 57.2
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Chills: Any
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Chills: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Chills: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
13.3 Percentage of participants
95% Confidence Interval 1.7 • Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Vomiting: Any
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Vomiting: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Diarrhea: Any
|
25.0 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 57.2
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Diarrhea: Mild
|
25.0 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 57.2
|
10.5 Percentage of participants
95% Confidence Interval 1.3 • Interval 1.3 to 33.1
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
5.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 26.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Any
|
16.7 Percentage of participants
95% Confidence Interval 2.1 • Interval 2.1 to 48.4
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Moderate
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Severe
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Any
|
25.0 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 57.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Mild
|
8.3 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 38.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
6.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Moderate
|
16.7 Percentage of participants
95% Confidence Interval 2.1 • Interval 2.1 to 48.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 17.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=4 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=3 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Diarrhea: Any
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fever: Any
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fever: >38.4 to 38.9 deg C
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fatigue: Any
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fatigue: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fatigue: Moderate
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Headache: Any
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Headache: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Headache: Moderate
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Chills: Any
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Chills: Mild
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Chills: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Diarrhea: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Any
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Moderate
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Any
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Moderate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after Vaccination 4Population: Safety population consisted of all participants who received at least 1 dose of study intervention.Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Participants of \>=18 years Haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=3 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fever: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fever: >=38.0 to 38.4 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fever: >38.4 to 38.9 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fever: >40.0 deg C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fatigue: Any
|
66.7 Percentage of participants
95% Confidence Interval 9.4 • Interval 9.4 to 99.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fatigue: Mild
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fatigue: Moderate
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fatigue: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Fatigue: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Headache: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Headache: Mild
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Headache: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Headache: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Headache: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Chills: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Chills: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Chills: Moderate
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Chills: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Chills: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Vomiting: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Vomiting: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Vomiting: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Vomiting: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Vomiting: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Diarrhea: Any
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Diarrhea: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Diarrhea: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Diarrhea: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Diarrhea: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened muscle pain: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened muscle pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened muscle pain: Moderate
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened muscle pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened joint pain: Any
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened joint pain: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened joint pain: Moderate
|
33.3 Percentage of participants
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened joint pain: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
|
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
New or worsened joint pain: Grade 4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years
|
44.4 Percentage of participants
95% Confidence Interval 13.7 • Interval 13.7 to 78.8
|
33.3 Percentage of participants
95% Confidence Interval 11.8 • Interval 11.8 to 61.6
|
38.5 Percentage of participants
95% Confidence Interval 13.9 • Interval 13.9 to 68.4
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years
|
36.8 Percentage of participants
Interval 16.3 to 61.6
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: From Vaccination 3 to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=11 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years
|
33.3 Percentage of participants
95% Confidence Interval 7.5 • Interval 7.5 to 70.1
|
40.0 Percentage of participants
95% Confidence Interval 16.3 • Interval 16.3 to 67.7
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 28.5
|
PRIMARY outcome
Timeframe: From Vaccination 3 to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=17 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=23 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years
|
29.4 Percentage of participants
95% Confidence Interval 10.3 • Interval 10.3 to 56.0
|
8.7 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 28.0
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
PRIMARY outcome
Timeframe: From Vaccination 3 to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
PRIMARY outcome
Timeframe: From Vaccination 3 to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 52.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=6 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
16.7 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=12 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=19 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 26.5
|
36.8 Percentage of participants
95% Confidence Interval 16.3 • Interval 16.3 to 61.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=4 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=3 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 60.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
PRIMARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.Participants of \>=18 years with Haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=3 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 70.8
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
—
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)Population: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 33.6
|
53.3 Percentage of participants
95% Confidence Interval 26.6 • Interval 26.6 to 78.7
|
23.1 Percentage of participants
95% Confidence Interval 5.0 • Interval 5.0 to 53.8
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)Population: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=19 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=24 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=22 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years
|
15.8 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 39.6
|
20.8 Percentage of participants
95% Confidence Interval 7.1 • Interval 7.1 to 42.2
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)Population: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=7 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=7 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)Population: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=5 Participants
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=1 Participants
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
|---|---|---|---|
|
Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years
|
20.0 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
100.0 Percentage of participants
95% Confidence Interval 2.5 • Interval 2.5 to 100.0
|
Adverse Events
>=2 to <5 Years With Immunomodulatory Therapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
>=2 to <5 Years With Solid Organ Transplant
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
>=2 to <5 Years With Stem Cell Transplant
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
>=5 to <12 Years With Immunomodulatory Therapy
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
>=5 to <12 Years With Solid Organ Transplant
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
>=5 to <12 Years With Stem Cell Transplant
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
>=12 to <18 Years With Immunomodulatory Therapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
>=12 to <18 Years With Solid Organ Transplant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
>=12 to <18 Years With Stem Cell Transplant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
>=18 Years With Immunomodulatory Therapy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
>=18 Years With Non-Small Cell Lung Cancer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
>= 18 Years With Haemodialysis
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 participants at risk
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 participants at risk
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 participants at risk
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Immunomodulatory Therapy
n=19 participants at risk
Participants aged \>=5 to \<12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Solid Organ Transplant
n=24 participants at risk
Participants aged \>=5 to \<12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Stem Cell Transplant
n=22 participants at risk
Participants aged \>=5 to \<12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Immunomodulatory Therapy
n=7 participants at risk
Participants aged \>=12 to \<18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Solid Organ Transplant
n=1 participants at risk
Participants aged \>=12 to \<18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Stem Cell Transplant
n=7 participants at risk
Participants aged \>=12 to \<18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Immunomodulatory Therapy
n=5 participants at risk
Participants aged \>=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Non-Small Cell Lung Cancer
n=1 participants at risk
Participants with non-small cell lung cancer aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>= 18 Years With Haemodialysis
n=1 participants at risk
Participants undergone maintenance haemodialysis treatment aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Device related infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Gangrene
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
13.3%
2/15 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
13.3%
2/15 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Surgical and medical procedures
Catheter removal
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
Other adverse events
| Measure |
>=2 to <5 Years With Immunomodulatory Therapy
n=9 participants at risk
Participants aged \>=2 to \<5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Solid Organ Transplant
n=15 participants at risk
Participants aged \>=2 to \<5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=2 to <5 Years With Stem Cell Transplant
n=13 participants at risk
Participants aged \>=2 to \<5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Immunomodulatory Therapy
n=19 participants at risk
Participants aged \>=5 to \<12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Solid Organ Transplant
n=24 participants at risk
Participants aged \>=5 to \<12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=5 to <12 Years With Stem Cell Transplant
n=22 participants at risk
Participants aged \>=5 to \<12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Immunomodulatory Therapy
n=7 participants at risk
Participants aged \>=12 to \<18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Solid Organ Transplant
n=1 participants at risk
Participants aged \>=12 to \<18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=12 to <18 Years With Stem Cell Transplant
n=7 participants at risk
Participants aged \>=12 to \<18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Immunomodulatory Therapy
n=5 participants at risk
Participants aged \>=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>=18 Years With Non-Small Cell Lung Cancer
n=1 participants at risk
Participants with non-small cell lung cancer aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
|
>= 18 Years With Haemodialysis
n=1 participants at risk
Participants undergone maintenance haemodialysis treatment aged \>=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Impetigo
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
12.5%
3/24 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Otitis media
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Investigations
Blood iron decreased
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Investigations
Body temperature increased
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Investigations
Donor specific antibody present
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Congenital, familial and genetic disorders
Tumour necrosis factor receptor-associated periodic syndrome
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Nervous system disorders
Headache (HEADACHE)
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
57.9%
11/19 • Number of events 25 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
45.8%
11/24 • Number of events 16 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
40.9%
9/22 • Number of events 17 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
7/7 • Number of events 15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
85.7%
6/7 • Number of events 8 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
80.0%
4/5 • Number of events 9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Amblyopia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Eye discharge
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Eye irritation
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Photophobia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Eye disorders
Uveitis
|
11.1%
1/9 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
8.3%
2/24 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
22.2%
2/9 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
15.4%
2/13 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
26.3%
5/19 • Number of events 8 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.8%
5/24 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
9.1%
2/22 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
60.0%
3/5 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
8.3%
2/24 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
9.1%
2/22 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
30.8%
4/13 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
10.5%
2/19 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
16.7%
4/24 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (NEW OR WORSENED JOINT PAIN)
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
21.1%
4/19 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
8.3%
2/24 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
13.6%
3/22 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
40.0%
2/5 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (NEW OR WORSENED MUSCLE PAIN)
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
31.6%
6/19 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
33.3%
8/24 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
13.6%
3/22 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
40.0%
2/5 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
8.3%
2/24 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
12.5%
3/24 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Viral rash
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Viral rhinitis
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Viral sinusitis
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
11.1%
1/9 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Chest pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Chills
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Chills (CHILLS)
|
22.2%
2/9 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
36.8%
7/19 • Number of events 9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
12.5%
3/24 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
22.7%
5/22 • Number of events 7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
71.4%
5/7 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
40.0%
2/5 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Erythema (REDNESS)
|
33.3%
3/9 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
36.8%
7/19 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.8%
5/24 • Number of events 7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
27.3%
6/22 • Number of events 13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Fatigue (FATIGUE)
|
33.3%
3/9 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
23.1%
3/13 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
73.7%
14/19 • Number of events 34 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
70.8%
17/24 • Number of events 31 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
63.6%
14/22 • Number of events 31 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
85.7%
6/7 • Number of events 18 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
71.4%
5/7 • Number of events 10 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
80.0%
4/5 • Number of events 11 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Injection site bruising
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.2%
1/24 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Pyrexia (FEVER)
|
22.2%
2/9 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
15.4%
2/13 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
10.5%
2/19 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
8.3%
2/24 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
22.7%
5/22 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
42.9%
3/7 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Injection site pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
44.4%
4/9 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
3/15 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
30.8%
4/13 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
84.2%
16/19 • Number of events 50 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
75.0%
18/24 • Number of events 43 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
86.4%
19/22 • Number of events 40 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
85.7%
6/7 • Number of events 20 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 4 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
71.4%
5/7 • Number of events 12 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
80.0%
4/5 • Number of events 13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Medical device site inflammation
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
13.3%
2/15 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
14.3%
1/7 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
General disorders
Swelling (SWELLING)
|
11.1%
1/9 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
7.7%
1/13 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
26.3%
5/19 • Number of events 8 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
16.7%
4/24 • Number of events 6 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
36.4%
8/22 • Number of events 17 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 8 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
100.0%
1/1 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
28.6%
2/7 • Number of events 3 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
20.0%
1/5 • Number of events 2 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
6.7%
1/15 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
5.3%
1/19 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/22 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/9 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/15 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/13 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/19 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/24 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
4.5%
1/22 • Number of events 1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/7 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/5 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
0.00%
0/1 • Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
|
Additional Information
BioNTech SE
BioNTech clinical trials patient information
Phone: +49 6131 90840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER