Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants (NCT NCT05782179)
NCT ID: NCT05782179
Last Updated: 2025-09-05
Results Overview
* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
Up to 28 days after each vaccination
Results posted on
2025-09-05
Participant Flow
Overall, 90 participants were enrolled and randomised.
Participant milestones
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
12
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
24
|
24
|
10
|
12
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
Baseline characteristics by cohort
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
65.4 years
STANDARD_DEVIATION 4.6 • n=21 Participants
|
65.8 years
STANDARD_DEVIATION 1.3 • n=8 Participants
|
65.1 years
STANDARD_DEVIATION 5.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Height
|
167.81 cm
STANDARD_DEVIATION 10.50 • n=5 Participants
|
168.98 cm
STANDARD_DEVIATION 7.58 • n=7 Participants
|
167.12 cm
STANDARD_DEVIATION 7.85 • n=5 Participants
|
171.88 cm
STANDARD_DEVIATION 9.36 • n=4 Participants
|
169.15 cm
STANDARD_DEVIATION 11.67 • n=21 Participants
|
172.00 cm
STANDARD_DEVIATION 14.49 • n=8 Participants
|
169.03 cm
STANDARD_DEVIATION 9.65 • n=8 Participants
|
|
Weight
|
70.98 Kg
STANDARD_DEVIATION 13.16 • n=5 Participants
|
70.65 Kg
STANDARD_DEVIATION 7.45 • n=7 Participants
|
68.88 Kg
STANDARD_DEVIATION 11.75 • n=5 Participants
|
95.68 Kg
STANDARD_DEVIATION 12.54 • n=4 Participants
|
95.38 Kg
STANDARD_DEVIATION 14.09 • n=21 Participants
|
95.07 Kg
STANDARD_DEVIATION 11.91 • n=8 Participants
|
78.76 Kg
STANDARD_DEVIATION 16.41 • n=8 Participants
|
|
Body Mass Index (BMI)
|
24.993 kg/m^2
STANDARD_DEVIATION 2.537 • n=5 Participants
|
24.808 kg/m^2
STANDARD_DEVIATION 2.854 • n=7 Participants
|
24.668 kg/m^2
STANDARD_DEVIATION 3.856 • n=5 Participants
|
32.262 kg/m^2
STANDARD_DEVIATION 1.584 • n=4 Participants
|
33.323 kg/m^2
STANDARD_DEVIATION 3.340 • n=21 Participants
|
32.437 kg/m^2
STANDARD_DEVIATION 5.123 • n=8 Participants
|
27.476 kg/m^2
STANDARD_DEVIATION 4.772 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after each vaccination* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
Local Solicited AEs
|
23 Participants
|
21 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
|
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
Systemic Solicited AEs
|
12 Participants
|
14 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
|
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
Unsolicited AEs
|
17 Participants
|
16 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
4 Participants
|
|
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
AEs leading to withdrawal
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 197Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint).
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=10 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Anti-Alp1
|
13.14 μg/mL
Interval 9.18 to 18.81
|
12.34 μg/mL
Interval 9.62 to 15.83
|
0.08 μg/mL
Interval 0.03 to 0.21
|
8.34 μg/mL
Interval 4.45 to 15.62
|
14.17 μg/mL
Interval 7.73 to 25.95
|
0.15 μg/mL
Interval 0.06 to 0.35
|
|
Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Anti-Alp2/3
|
12.69 μg/mL
Interval 9.26 to 17.39
|
17.39 μg/mL
Interval 9.36 to 19.51
|
0.04 μg/mL
Interval 0.02 to 0.08
|
10.90 μg/mL
Interval 5.52 to 21.52
|
14.52 μg/mL
Interval 8.92 to 23.65
|
0.09 μg/mL
Interval 0.02 to 0.42
|
|
Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Anti-AlpC
|
13.69 μg/mL
Interval 9.82 to 19.09
|
11.28 μg/mL
Interval 7.15 to 17.8
|
0.04 μg/mL
Interval 0.02 to 0.11
|
6.64 μg/mL
Interval 2.64 to 16.68
|
14.11 μg/mL
Interval 5.05 to 39.44
|
0.10 μg/mL
Interval 0.03 to 0.35
|
|
Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Anti-Rib
|
4.76 μg/mL
Interval 2.84 to 7.97
|
4.55 μg/mL
Interval 2.78 to 7.46
|
0.04 μg/mL
Interval 0.02 to 0.08
|
3.67 μg/mL
Interval 1.82 to 7.39
|
4.59 μg/mL
Interval 1.58 to 13.37
|
0.06 μg/mL
Interval 0.02 to 0.16
|
SECONDARY outcome
Timeframe: 4 weeks after each vaccination (Days 29, 57 and 197)Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp2/3 - Day 57
|
72.60 Geometric mean fold ratio
Interval 51.19 to 102.96
|
76.23 Geometric mean fold ratio
Interval 51.23 to 113.42
|
1.03 Geometric mean fold ratio
Interval 0.93 to 1.15
|
39.29 Geometric mean fold ratio
Interval 16.2 to 95.28
|
84.82 Geometric mean fold ratio
Interval 41.61 to 172.89
|
0.88 Geometric mean fold ratio
Interval 0.74 to 1.05
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp1 - Day 29
|
34.04 Geometric mean fold ratio
Interval 18.65 to 62.13
|
24.99 Geometric mean fold ratio
Interval 14.12 to 44.24
|
1.04 Geometric mean fold ratio
Interval 0.98 to 1.1
|
21.27 Geometric mean fold ratio
Interval 6.47 to 69.87
|
43.16 Geometric mean fold ratio
Interval 17.67 to 105.44
|
0.78 Geometric mean fold ratio
Interval 0.47 to 1.3
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp1- Day 57
|
70.98 Geometric mean fold ratio
Interval 44.71 to 112.67
|
39.71 Geometric mean fold ratio
Interval 25.59 to 61.63
|
1.09 Geometric mean fold ratio
Interval 0.99 to 1.19
|
32.86 Geometric mean fold ratio
Interval 17.58 to 61.42
|
47.89 Geometric mean fold ratio
Interval 25.05 to 91.56
|
0.84 Geometric mean fold ratio
Interval 0.63 to 1.11
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp1 - Day 197
|
124.30 Geometric mean fold ratio
Interval 79.84 to 193.52
|
106.77 Geometric mean fold ratio
Interval 69.83 to 163.23
|
0.85 Geometric mean fold ratio
Interval 0.48 to 1.49
|
56.11 Geometric mean fold ratio
Interval 29.99 to 104.99
|
114.75 Geometric mean fold ratio
Interval 74.02 to 177.89
|
1.46 Geometric mean fold ratio
Interval 0.45 to 4.77
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp2/3 - Day 29
|
40.97 Geometric mean fold ratio
Interval 27.11 to 61.92
|
50.32 Geometric mean fold ratio
Interval 29.3 to 86.45
|
0.98 Geometric mean fold ratio
Interval 0.9 to 1.07
|
20.17 Geometric mean fold ratio
Interval 4.26 to 95.44
|
82.64 Geometric mean fold ratio
Interval 30.33 to 225.14
|
0.66 Geometric mean fold ratio
Interval 0.24 to 1.79
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Alp2/3 - Day 197
|
148.15 Geometric mean fold ratio
Interval 103.14 to 212.79
|
204.85 Geometric mean fold ratio
Interval 131.19 to 319.86
|
0.69 Geometric mean fold ratio
Interval 0.37 to 1.28
|
89.51 Geometric mean fold ratio
Interval 39.87 to 200.93
|
205.88 Geometric mean fold ratio
Interval 102.76 to 412.5
|
1.09 Geometric mean fold ratio
Interval 0.39 to 3.02
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
AlpC - Day 29
|
59.09 Geometric mean fold ratio
Interval 36.75 to 95.01
|
31.75 Geometric mean fold ratio
Interval 16.42 to 61.4
|
1.10 Geometric mean fold ratio
Interval 1.02 to 1.17
|
29.37 Geometric mean fold ratio
Interval 6.67 to 129.21
|
45.62 Geometric mean fold ratio
Interval 16.18 to 128.63
|
0.63 Geometric mean fold ratio
Interval 0.24 to 1.71
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
AlpC - Day 57
|
102.29 Geometric mean fold ratio
Interval 65.31 to 160.21
|
38.89 Geometric mean fold ratio
Interval 21.45 to 70.5
|
1.15 Geometric mean fold ratio
Interval 1.04 to 1.28
|
40.66 Geometric mean fold ratio
Interval 15.51 to 106.59
|
44.84 Geometric mean fold ratio
Interval 20.39 to 98.61
|
0.87 Geometric mean fold ratio
Interval 0.69 to 1.09
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
AlpC - Day 197
|
115.60 Geometric mean fold ratio
Interval 76.71 to 174.19
|
114.30 Geometric mean fold ratio
Interval 67.9 to 192.4
|
0.45 Geometric mean fold ratio
Interval 0.26 to 0.77
|
60.42 Geometric mean fold ratio
Interval 23.95 to 152.45
|
91.27 Geometric mean fold ratio
Interval 43.68 to 190.72
|
0.95 Geometric mean fold ratio
Interval 0.23 to 3.95
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Rib - Day 29
|
18.56 Geometric mean fold ratio
Interval 11.85 to 29.09
|
26.62 Geometric mean fold ratio
Interval 14.61 to 48.53
|
1.03 Geometric mean fold ratio
Interval 0.97 to 1.09
|
25.74 Geometric mean fold ratio
Interval 8.03 to 82.57
|
20.95 Geometric mean fold ratio
Interval 5.94 to 73.86
|
1.00 Geometric mean fold ratio
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Rib - Day 57
|
30.74 Geometric mean fold ratio
Interval 20.83 to 45.37
|
34.87 Geometric mean fold ratio
Interval 22.59 to 53.83
|
1.09 Geometric mean fold ratio
Interval 1.0 to 1.18
|
36.74 Geometric mean fold ratio
Interval 15.4 to 87.64
|
24.06 Geometric mean fold ratio
Interval 9.96 to 58.09
|
1.10 Geometric mean fold ratio
Interval 0.76 to 1.61
|
|
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Rib - Day 197
|
47.74 Geometric mean fold ratio
Interval 31.94 to 71.35
|
69.42 Geometric mean fold ratio
Interval 42.27 to 114.01
|
0.68 Geometric mean fold ratio
Interval 0.45 to 1.03
|
54.05 Geometric mean fold ratio
Interval 25.53 to 114.4
|
37.74 Geometric mean fold ratio
Interval 15.31 to 93.03
|
0.58 Geometric mean fold ratio
Interval 0.26 to 1.27
|
SECONDARY outcome
Timeframe: Up to 6 months after last vaccinationSeroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp1 (µg/mL) - Day 29
|
22 participants
|
21 participants
|
0 participants
|
9 participants
|
11 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp1 - Day 57
|
23 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp1 - Day 169
|
23 participants
|
24 participants
|
0 participants
|
11 participants
|
12 participants
|
1 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp1 - Day 197
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
1 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp1 - Day 365
|
23 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
1 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp2/3 - Day 29
|
24 participants
|
23 participants
|
0 participants
|
7 participants
|
11 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp2/3 - Day 57
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp2/3 - Day 169
|
24 participants
|
24 participants
|
0 participants
|
11 participants
|
12 participants
|
1 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp2/3 - Day 197
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
1 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Alp2/3 - Day 365
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-AlpC - Day 29
|
24 participants
|
21 participants
|
0 participants
|
8 participants
|
11 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-AlpC - Day 57
|
24 participants
|
24 participants
|
0 participants
|
11 participants
|
12 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-AlpC - Day 169
|
24 participants
|
20 participants
|
0 participants
|
11 participants
|
10 participants
|
2 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-AlpC - Day 197
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
2 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-AlpC - Day 365
|
24 participants
|
22 participants
|
0 participants
|
12 participants
|
11 participants
|
2 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Rib - Day 29
|
22 participants
|
21 participants
|
0 participants
|
10 participants
|
10 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Rib - Day 57
|
23 participants
|
24 participants
|
0 participants
|
11 participants
|
10 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Rib - Day 169
|
21 participants
|
21 participants
|
0 participants
|
11 participants
|
10 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Rib - Day 197
|
23 participants
|
24 participants
|
0 participants
|
12 participants
|
11 participants
|
0 participants
|
|
Seroconversion Rate at Any Time Post Vaccination
Anti-Rib - Day 365
|
22 participants
|
22 participants
|
0 participants
|
12 participants
|
10 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to day 197Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (\>1, \>2, \>4, and \>8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose.
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >1 µg/mL - Day 57
|
23 participants
|
23 participants
|
0 participants
|
10 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >1 µg/mL - Day 169
|
21 participants
|
20 participants
|
0 participants
|
9 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >2 µg/mL - Day 57
|
22 participants
|
18 participants
|
0 participants
|
9 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >2 µg/mL - Day 169
|
18 participants
|
14 participants
|
0 participants
|
7 participants
|
7 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >4 µg/mL - Day 57
|
17 participants
|
16 participants
|
0 participants
|
9 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >4 µg/mL - Day 169
|
11 participants
|
11 participants
|
0 participants
|
7 participants
|
6 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >2 µg/mL - Day 29
|
21 participants
|
15 participants
|
0 participants
|
7 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >2 µg/mL - Day 57
|
21 participants
|
16 participants
|
0 participants
|
9 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >2 µg/mL - Day 169
|
21 participants
|
18 participants
|
0 participants
|
6 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >4 µg/mL - Day 29
|
15 participants
|
12 participants
|
0 participants
|
6 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >4 µg/mL - Day 57
|
20 participants
|
12 participants
|
0 participants
|
6 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >4 µg/mL - Day 169
|
15 participants
|
10 participants
|
0 participants
|
4 participants
|
6 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >8 µg/mL - Day 29
|
11 participants
|
7 participants
|
0 participants
|
5 participants
|
7 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >8 µg/mL - Day 57
|
19 participants
|
9 participants
|
0 participants
|
5 participants
|
7 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >1 µg/mL - Day 169
|
20 participants
|
20 participants
|
0 participants
|
9 participants
|
12 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >1 µg/mL - Day 197
|
23 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >2 µg/mL - Day 29
|
16 participants
|
16 participants
|
0 participants
|
7 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >2 µg/mL - Day 197
|
23 participants
|
24 participants
|
0 participants
|
11 participants
|
12 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >4 µg/mL - Day 29
|
13 participants
|
11 participants
|
0 participants
|
7 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >4 µg/mL - Day 57
|
17 participants
|
12 participants
|
0 participants
|
7 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >4 µg/mL - Day 169
|
12 participants
|
7 participants
|
0 participants
|
4 participants
|
6 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >4 µg/mL - Day 197
|
23 participants
|
24 participants
|
0 participants
|
10 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >8 µg/mL - Day 29
|
8 participants
|
5 participants
|
0 participants
|
4 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >8 µg/mL - Day 57
|
13 participants
|
8 participants
|
0 participants
|
5 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >8 µg/mL - Day 169
|
8 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >8 µg/mL - Day 197
|
19 participants
|
18 participants
|
0 participants
|
5 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >1 µg/mL - Day 29
|
20 participants
|
20 participants
|
0 participants
|
8 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >1 µg/mL - Day 57
|
23 participants
|
21 participants
|
0 participants
|
9 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >1 µg/mL - Day 197
|
24 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >2 µg/mL - Day 29
|
17 participants
|
17 participants
|
0 participants
|
8 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >2 µg/mL - Day 57
|
20 participants
|
19 participants
|
0 participants
|
9 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >2 µg/mL - Day 169
|
18 participants
|
16 participants
|
0 participants
|
8 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp 1 >1 µg/mL - Day 29
|
19 participants
|
19 participants
|
0 participants
|
8 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >2 µg/mL - Day 197
|
23 participants
|
24 participants
|
0 participants
|
12 participants
|
12 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >4 µg/mL - Day 29
|
12 participants
|
12 participants
|
0 participants
|
7 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >4 µg/mL - Day 197
|
23 participants
|
21 participants
|
0 participants
|
10 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >8 µg/mL - Day 29
|
6 participants
|
5 participants
|
0 participants
|
4 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >8 µg/mL - Day 57
|
9 participants
|
7 participants
|
0 participants
|
6 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >8 µg/mL - Day 169
|
5 participants
|
4 participants
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Alp2/3 >8 µg/mL - Day 197
|
19 participants
|
18 participants
|
0 participants
|
8 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >1 µg/mL - Day 29
|
18 participants
|
18 participants
|
0 participants
|
8 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >1 µg/mL - Day 57
|
20 participants
|
18 participants
|
0 participants
|
9 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >1 µg/mL - Day 169
|
18 participants
|
14 participants
|
0 participants
|
8 participants
|
6 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >1 µg/mL - Day 197
|
22 participants
|
20 participants
|
0 participants
|
11 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >2 µg/mL - Day 29
|
13 participants
|
11 participants
|
0 participants
|
6 participants
|
8 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >2 µg/mL - Day 57
|
18 participants
|
16 participants
|
0 participants
|
8 participants
|
7 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >2 µg/mL - Day 169
|
11 participants
|
12 participants
|
0 participants
|
6 participants
|
4 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >2 µg/mL - Day 197
|
19 participants
|
20 participants
|
0 participants
|
9 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >4 µg/mL - Day 29
|
7 participants
|
9 participants
|
0 participants
|
4 participants
|
6 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >4 µg/mL - Day 57
|
11 participants
|
11 participants
|
0 participants
|
5 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >4 µg/mL - Day 169
|
6 participants
|
4 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >4 µg/mL - Day 197
|
16 participants
|
16 participants
|
0 participants
|
6 participants
|
7 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >8 µg/mL - Day 29
|
3 participants
|
2 participants
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >8 µg/mL - Day 57
|
5 participants
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >8 µg/mL - Day 169
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Rib >8 µg/mL - Day 197
|
9 participants
|
9 participants
|
0 participants
|
4 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >1 µg/mL - Day 29
|
22 participants
|
17 participants
|
0 participants
|
8 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >1 µg/mL - Day 57
|
23 participants
|
18 participants
|
0 participants
|
10 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >1 µg/mL - Day 169
|
22 participants
|
19 participants
|
0 participants
|
9 participants
|
9 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >1 µg/mL - Day 197
|
24 participants
|
24 participants
|
0 participants
|
11 participants
|
11 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >2 µg/mL - Day 197
|
23 participants
|
22 participants
|
0 participants
|
10 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >4 µg/mL - Day 157
|
23 participants
|
20 participants
|
0 participants
|
6 participants
|
10 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >8 µg/mL - Day 169
|
5 participants
|
5 participants
|
0 participants
|
3 participants
|
5 participants
|
0 participants
|
|
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
AlpC >8 µg/mL - Day 197
|
21 participants
|
17 participants
|
0 participants
|
6 participants
|
9 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to day 365* Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. * Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.
Outcome measures
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 Participants
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 Participants
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 Participants
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 Participants
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
SAE from Day 197 to Day 365
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
SAE from Day 57 to Day 168
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
MAAEs from Day 197 up to Day 365
|
12 participants
|
9 participants
|
2 participants
|
1 participants
|
5 participants
|
2 participants
|
|
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
AESIs from Day 197 up to Day 365
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
ARs/SARs from Day 197 up to Day 365
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Healthy Older Adult : GBS-NN/NN2 50 µg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Healthy Older Adult : GBS-NN/NN2 125 µg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Healthy Older Adult : Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Obese and/or Diabetic Older Adult : Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 participants at risk
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 participants at risk
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 participants at risk
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 participants at risk
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 participants at risk
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 participants at risk
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
Other adverse events
| Measure |
Healthy Older Adult : GBS-NN/NN2 50 µg
n=24 participants at risk
Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : GBS-NN/NN2 125 µg
n=24 participants at risk
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Healthy Older Adult : Placebo
n=12 participants at risk
Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg
n=12 participants at risk
Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
n=12 participants at risk
Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Obese and/or Diabetic Older Adult : Placebo
n=6 participants at risk
Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 %
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Eye disorders
Eye irritation
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
1/6 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Fatigue
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
20.8%
5/24 • Number of events 5 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
1/6 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Injection site warmth
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Malaise
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Oedema
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Pain
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
General disorders
Vessel puncture site haemorrhage
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Cystitis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Fungal infection
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Gingivitis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
20.8%
5/24 • Number of events 5 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Paronychia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Infections and infestations
Joint injury
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
1/6 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
1/6 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Investigations
Blood pressure systolic increased
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Metabolism and nutrition disorders
Gout
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
1/6 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Nervous system disorders
Sciatica
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Renal and urinary disorders
Dysuria
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
3/24 • Number of events 3 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
16.7%
2/12 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Vascular disorders
Haematoma
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/24 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
8.3%
1/12 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
|
Vascular disorders
Hypertension
|
8.3%
2/24 • Number of events 2 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/12 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
0.00%
0/6 • All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
|
Additional Information
Cornelia Oostvogels/Chief Medical Officer (CMO)
MinervaX
Phone: 00491515092821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place