Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria (NCT NCT06069544)
NCT ID: NCT06069544
Last Updated: 2026-08-28
Results Overview
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the study participant. Confirmation by an investigator or medically qualified person was required for all Grade 3 or 4 reactogenicity events. Grades were defined as: Grade 1 - Mild; does not interfere with the study participant's activity; Grade 2 - Moderate; interferes with the study participant's activity; Grade 3 - Severe; prevents study participant's daily activity; and Grade 4 - Potentially life-threatening; emergency room visit or hospitalization for severe pain. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Up to 7 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3)
Results posted on
2026-08-28
Participant Flow
Participant milestones
| Measure |
BNT165c 10 mcg
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
Placebo (0-1-2)
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Doses were given at 0-1-2 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
10
|
26
|
30
|
10
|
25
|
2
|
|
Overall Study
Vaccinated with Dose 1
|
10
|
10
|
10
|
10
|
10
|
10
|
10
|
26
|
30
|
10
|
25
|
2
|
|
Overall Study
Vaccinated with Dose 2
|
10
|
9
|
9
|
9
|
9
|
9
|
9
|
15
|
15
|
10
|
19
|
2
|
|
Overall Study
Vaccinated with Dose 3
|
9
|
7
|
7
|
7
|
9
|
8
|
9
|
2
|
0
|
8
|
12
|
2
|
|
Overall Study
COMPLETED
|
9
|
5
|
6
|
7
|
8
|
8
|
9
|
2
|
0
|
7
|
12
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
4
|
3
|
2
|
2
|
1
|
24
|
30
|
3
|
13
|
1
|
Reasons for withdrawal
| Measure |
BNT165c 10 mcg
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
Placebo (0-1-2)
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Doses were given at 0-1-2 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
2
|
3
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
1
|
0
|
2
|
0
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Subject incarcerated
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Follow-up after treatment discontinuation as per protocol
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
12
|
15
|
2
|
4
|
0
|
|
Overall Study
Participant does not wish to continue receiving IMP but still consents to safety follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant moved out of the country
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study participation ongoing
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
12
|
0
|
5
|
0
|
Baseline Characteristics
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
Baseline characteristics by cohort
| Measure |
BNT165c 10 Micrograms (mcg)
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%). Doses were given at 0-1-2 months.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 10.71 • n=31 Participants
|
38.3 years
STANDARD_DEVIATION 8.68 • n=49 Participants
|
40.8 years
STANDARD_DEVIATION 10.2 • n=80 Participants
|
37.0 years
STANDARD_DEVIATION 9.52 • n=29 Participants
|
38.7 years
STANDARD_DEVIATION 9.57 • n=106 Participants
|
36.7 years
STANDARD_DEVIATION 7.44 • n=6 Participants
|
39.3 years
STANDARD_DEVIATION 7.54 • n=6 Participants
|
42.3 years
STANDARD_DEVIATION 10.49 • n=48 Participants
|
39.5 years
STANDARD_DEVIATION 10.33 • n=10 Participants
|
41.0 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 8.57 • n=10 Participants
|
39.0 years
STANDARD_DEVIATION 14.14 • n=12 Participants
|
39.3 years
STANDARD_DEVIATION 9.49 • n=14 Participants
|
|
Body Mass Index
|
27.87 kg/m^2
STANDARD_DEVIATION 5.149 • n=31 Participants
|
27.86 kg/m^2
STANDARD_DEVIATION 4.365 • n=49 Participants
|
28.23 kg/m^2
STANDARD_DEVIATION 3.566 • n=80 Participants
|
28.47 kg/m^2
STANDARD_DEVIATION 3.515 • n=29 Participants
|
24.83 kg/m^2
STANDARD_DEVIATION 4.815 • n=106 Participants
|
26.43 kg/m^2
STANDARD_DEVIATION 4.662 • n=6 Participants
|
29.46 kg/m^2
STANDARD_DEVIATION 3.549 • n=6 Participants
|
27.39 kg/m^2
STANDARD_DEVIATION 4.154 • n=48 Participants
|
27.45 kg/m^2
STANDARD_DEVIATION 4.179 • n=10 Participants
|
28.46 kg/m^2
STANDARD_DEVIATION 4.341 • n=5 Participants
|
28.15 kg/m^2
STANDARD_DEVIATION 4.267 • n=10 Participants
|
32.10 kg/m^2
STANDARD_DEVIATION 2.404 • n=12 Participants
|
27.73 kg/m^2
STANDARD_DEVIATION 4.228 • n=14 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
6 Participants
n=106 Participants
|
8 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
14 Participants
n=48 Participants
|
17 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
83 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
4 Participants
n=106 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
12 Participants
n=48 Participants
|
13 Participants
n=10 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
80 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=48 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
37 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
7 Participants
n=106 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
23 Participants
n=48 Participants
|
23 Participants
n=10 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
126 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=48 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
23 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=31 Participants
|
8 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
9 Participants
n=29 Participants
|
6 Participants
n=106 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
20 Participants
n=48 Participants
|
25 Participants
n=10 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
129 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
100 percentage of participants
n=31 Participants
|
100 percentage of participants
n=49 Participants
|
100 percentage of participants
n=80 Participants
|
100 percentage of participants
n=29 Participants
|
100 percentage of participants
n=106 Participants
|
100 percentage of participants
n=6 Participants
|
100 percentage of participants
n=6 Participants
|
100 percentage of participants
n=48 Participants
|
100 percentage of participants
n=10 Participants
|
100 percentage of participants
n=5 Participants
|
100 percentage of participants
n=10 Participants
|
100 percentage of participants
n=12 Participants
|
100 percentage of participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3)Population: Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Participants in the BNT165c 70 mcg + BNT165d 30 mcg Arm/Group did not receive Dose 3; therefore, no data are available post-Dose 3 for this Arm/Group.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the study participant. Confirmation by an investigator or medically qualified person was required for all Grade 3 or 4 reactogenicity events. Grades were defined as: Grade 1 - Mild; does not interfere with the study participant's activity; Grade 2 - Moderate; interferes with the study participant's activity; Grade 3 - Severe; prevents study participant's daily activity; and Grade 4 - Potentially life-threatening; emergency room visit or hospitalization for severe pain. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Outcome measures
| Measure |
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
BNT165c 10 mcg
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Erythema/redness (any grade 1 - 4) - post any vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Pain at the injection site (any grade 1 - 4) - post Dose 2
|
0 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
3 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Erythema/redness (any grade 1 - 4) - post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Induration/swelling (any grade 1 - 4) - post Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Pain at the injection site (any grade 1 - 4) - post Dose 3
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
—
|
6 Participants
|
1 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Any local reaction grade >=3 - post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Induration/swelling (any grade 1 - 4) - post any vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Pain at the injection site (any grade 1 - 4) - post any vaccination
|
0 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
22 Participants
|
23 Participants
|
10 Participants
|
4 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Erythema/redness (any grade 1 - 4) - post Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Induration/swelling (any grade 1 - 4) - post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Pain at the injection site (any grade 1 - 4) - post Dose 1
|
0 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
18 Participants
|
22 Participants
|
8 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Erythema/redness (any grade 1 - 4) - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Induration/swelling (any grade 1 - 4) - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Any local reaction grade >=3 - post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Local Reactions at the Injection Site
Any local reaction grade >=3 - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3)Population: Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Participants in the BNT165c 70 mcg + BNT165d 30 mcg Arm/Group did not receive Dose 3; therefore, no data are available post-Dose 3 for this Arm/Group.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue/tiredness, muscle pain/joint pain, and fever. The intensity of AEs was graded by the participant but only an investigator or medically qualified person was able to classify a systemic reaction as Grade 3 or 4. Grades were defined as: Grade 1 - Mild; does not interfere with the study participant's activity; Grade 2 - Moderate; some interference with the study participant's activity; Grade 3 - Severe; prevents the trial participant's daily routine activity; and Grade 4 - Potentially life-threatening; Emergency room visit or hospitalization. Fever was categorized as 38.0 - 38.4 °C, 38.5 - 38.9 °C, 39.0 - 40.0 °C \& \>40.0 °C. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Outcome measures
| Measure |
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
BNT165c 10 mcg
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fever (any grade 1 - 4) - post any vaccination
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Diarrhea (any grade 1 - 4) - post any vaccination
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Headache (any grade 1 - 4) - post any vaccination
|
0 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
13 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fever (any grade 1 - 4) - post Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Vomiting (any grade 1 - 4) - post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Diarrhea (any grade 1 - 4) - post Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Muscle / joint pain (any grade 1 - 4) - post Dose 1
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
10 Participants
|
11 Participants
|
2 Participants
|
3 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fever (any grade 1 - 4) - post Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Diarrhea (any grade 1 - 4) - post Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Diarrhea (any grade 1 - 4) - post Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Headache (any grade 1 - 4) - post Dose 3
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
—
|
7 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fatigue / tiredness (any grade 1 - 4) - post Dose 3
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
—
|
5 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Vomiting (any grade 1 - 4) - post any vaccination
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fatigue / tiredness (any grade 1 - 4) - post any vaccination
|
0 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
16 Participants
|
14 Participants
|
8 Participants
|
9 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Muscle / joint pain (any grade 1 - 4) - post any vaccination
|
0 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
16 Participants
|
14 Participants
|
7 Participants
|
5 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Headache (any grade 1 - 4) - post Dose 1
|
0 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fatigue / tiredness (any grade 1 - 4) - post Dose 1
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
1 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Vomiting (any grade 1 - 4) - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Headache (any grade 1 - 4) - post Dose 2
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
4 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fatigue / tiredness (any grade 1 - 4) - post Dose 2
|
0 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Muscle / joint pain (any grade 1 - 4) - post Dose 2
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Fever (any grade 1 - 4) - post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
4 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Vomiting (any grade 1 - 4) - post Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Muscle / joint pain (any grade 1 - 4) - post Dose 3
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
—
|
6 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Any systemic reaction grade >=3 - post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Any systemic reaction grade >=3 - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactions
Any systemic reaction grade >=3 - post Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From administration of each IMP dose (i.e., Dose 1, Dose 2, and Dose 3) up to 28 days after the respective IMP dosePopulation: Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Participants in the BNT165c 70 mcg + BNT165d 30 mcg Arm/Group did not receive Dose 3; therefore, no data are available post-Dose 3 for this Arm/Group.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grade 1 - Mild; does not interfere with the trial subject's usual function; Grade 2 - Moderate; interferes to some extend with the trial subject's usual function Grade 3 - Severe; interferes significantly with the trial subject's usual function; and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses. Includes all unsolicited AEs and also solicited events that persisted beyond 7 days post-dose, qualify as an SAE, or are delayed local reactions.
Outcome measures
| Measure |
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
BNT165c 10 mcg
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event (AE)
Any grade >= 3 AE - post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Any grade >= 3 AE - post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Post Dose 3
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
5 Participants
|
1 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Any grade >= 3 AE - post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Post any vaccination
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Post Dose 1
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With at Least One Adverse Event (AE)
Post Dose 2
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Dose 1 up to 24 weeks after last received IMP dose, up to 13 months.Population: Analysis was performed on the safety set that included all participants who received at least one dose of the IMP.
An MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Includes all unsolicited AEs and also solicited events that qualify as an MAAE.
Outcome measures
| Measure |
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
BNT165c 10 mcg
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Medically Attended Adverse Event (MAAE)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From Dose 1 up to 24 weeks after last received IMP dose, up to 13 months.Population: Analysis was performed on the safety set that included all participants who received at least one dose of the IMP.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death or was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. Includes all unsolicited AEs and solicited events that qualify as an SAE.
Outcome measures
| Measure |
Placebo (0-1-2)
n=2 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
BNT165c 10 mcg
n=10 Participants
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 Participants
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 Participants
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 Participants
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 Participants
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 Participants
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 Participants
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 Participants
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 Participants
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 Participants
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 Participants
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 365 days after last received IMP doseFor each cohort - Anti-CSP immunoglobulin G
Outcome measures
Outcome data not reported
Adverse Events
BNT165c 10 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BNT165c 30 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BNT165c 70 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BNT165c 100 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BNT165d 30 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BNT165c 30 mcg + BNT165d 10 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BNT165c 10 mcg + BNT165d 30 mcg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
BNT165c 30 mcg + BNT165d 30 mcg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
BNT165c 70 mcg + BNT165d 30 mcg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (0-1-2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BNT165c 10 mcg
n=10 participants at risk
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 participants at risk
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 participants at risk
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 participants at risk
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 participants at risk
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 participants at risk
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 participants at risk
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 participants at risk
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 participants at risk
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 participants at risk
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 participants at risk
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
Placebo (0-1-2)
n=2 participants at risk
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocarditis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
Other adverse events
| Measure |
BNT165c 10 mcg
n=10 participants at risk
Cohort 1. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg
n=10 participants at risk
Cohort 2. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg
n=10 participants at risk
Cohort 3. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 100 mcg
n=10 participants at risk
Cohort 9. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165d 30 mcg
n=10 participants at risk
Cohort 4. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg
n=10 participants at risk
Cohort 5. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 10 mcg + BNT165d 30 mcg
n=10 participants at risk
Cohort 6. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 30 mcg
n=26 participants at risk
Cohort 7. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 70 mcg + BNT165d 30 mcg
n=30 participants at risk
Cohort 8. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-2-6 months.
|
BNT165c 30 mcg + BNT165d 10 mcg (0-1-2)
n=10 participants at risk
Cohort 10. Participants received 3 intramuscular injections of multi-antigen RNA-based vaccine for active immunization against malaria.
Doses were given at 0-1-2 months.
|
Placebo
n=25 participants at risk
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Includes placebo participants of all dose levels with a 0-2-6 months dose regimen.
|
Placebo (0-1-2)
n=2 participants at risk
Participants received 3 intramuscular injections of isotonic NaCl solution (0.9%).
Doses were given at 0-1-2 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
50.0%
1/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
7.7%
2/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Axillary pain
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Chest pain
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Fatigue
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
8.0%
2/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Injection site erythema
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Injection site pain
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Peripheral swelling
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
7.7%
2/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Ear infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Impetigo
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
3/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Lipoprotein (a) increased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Troponin increased
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Investigations
Vitamin D decreased
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
6.7%
2/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
50.0%
1/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Psychiatric disorders
Illness anxiety disorder
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
20.0%
2/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.3%
1/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
4.0%
1/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
3.8%
1/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
10.0%
1/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/26 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/30 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/10 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/25 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
0.00%
0/2 • AE data was collected from Dose 1 up to 28 days after each IMP dose, (i.e., post-Dose 1, post-Dose 2, and post-Dose 3), i.e., up to 8 months. All SAEs were collected from Visit 0 (Screening) up to end of study, i.e., up to ~20 months.
Analysis was performed on the safety set that included all participants who received at least one dose of the IMP. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-any IMP administration, were an SAE, or were delayed local reactions. Solicited local and systemic reactions are presented in the respective outcome measures (i.e., outcome measures #1 and #2).
|
Additional Information
BioNTech clinical trials patient information
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Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators respectively study sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER