Trial Outcomes & Findings for Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19 (NCT NCT06057064)
NCT ID: NCT06057064
Last Updated: 2025-08-15
Results Overview
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
up to Day 181
Results posted on
2025-08-15
Participant Flow
\[Not Specified\]
\[Not Specified\]
Participant milestones
| Measure |
AZD3152
AZD3152 300 mg
|
Placebo
Saline Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
29
|
|
Overall Study
COMPLETED
|
83
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
AZD3152
AZD3152 300 mg
|
Placebo
Saline Placebo
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
Baseline characteristics by cohort
| Measure |
AZD3152
n=87 Participants
AZD3152 300 mg
|
Placebo
n=29 Participants
Saline Placebo
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 Years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
|
Age, Customized
>= 18 to <60 years
|
52 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
35 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Previous COVID-19 vaccinations
|
56 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
SARS-CoV-2 status at baseline
Negative
|
87 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
SARS-CoV-2 status at baseline
Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
SARS-CoV-2 status at baseline
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Any COVID-19 comorbidities at baseline
Yes
|
87 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Any COVID-19 comorbidities at baseline
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Any high risk for severe COVID-19
Yes
|
87 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Any high risk for severe COVID-19
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
171.0 cm
STANDARD_DEVIATION 9.39 • n=5 Participants
|
170.7 cm
STANDARD_DEVIATION 8.80 • n=7 Participants
|
170.9 cm
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Baseline BMI
|
28.7 kg/m^2
STANDARD_DEVIATION 6.08 • n=5 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.30 • n=7 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to Day 181Population: Safety analysis population
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Outcome measures
| Measure |
AZD3152
n=87 Participants
AZD3152 300 mg
|
Placebo
n=29 Participants
Saline Placebo
|
|---|---|---|
|
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
Adverse Events
|
45 Participants
|
17 Participants
|
|
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
Serious Adverse Events
|
5 Participants
|
2 Participants
|
|
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
Medically Attended Adverse Events
|
14 Participants
|
7 Participants
|
|
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
Adverse Events of Special Interest
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Day 181Population: SARS-CoV-2 nAb Set
GMT of nAbs against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
Outcome measures
| Measure |
AZD3152
n=87 Participants
AZD3152 300 mg
|
Placebo
n=29 Participants
Saline Placebo
|
|---|---|---|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Baseline GMT
|
12.0 Titer
Standard Deviation 3.22
|
9.8 Titer
Standard Deviation 2.50
|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 2. Day 8 GMT
|
67.7 Titer
Standard Deviation 2.02
|
11.3 Titer
Standard Deviation 2.76
|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 3. Day 15 GMT
|
70.9 Titer
Standard Deviation 1.96
|
12.1 Titer
Standard Deviation 2.89
|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 4. Day 29 GMT
|
64.3 Titer
Standard Deviation 2.05
|
12.6 Titer
Standard Deviation 2.67
|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 5. Day 91 GMT
|
37.6 Titer
Standard Deviation 2.24
|
9.1 Titer
Standard Deviation 2.25
|
|
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 6. Day 181 GMT
|
22.4 Titer
Standard Deviation 2.71
|
13.4 Titer
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: up to Day 181Population: SARS-CoV-2 nAb Set
GMFR (from baseline) of nAb titers against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
Outcome measures
| Measure |
AZD3152
n=87 Participants
AZD3152 300 mg
|
Placebo
n=29 Participants
Saline Placebo
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 2. Day 8 GMFRs
|
5.63 fold rise
Standard Deviation 2.663
|
1.16 fold rise
Standard Deviation 1.941
|
|
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 3. Day 15 GMFRs
|
5.84 fold rise
Standard Deviation 2.491
|
1.24 fold rise
Standard Deviation 2.247
|
|
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 4. Day 29 GMFRs
|
4.71 fold rise
Standard Deviation 2.295
|
1.33 fold rise
Standard Deviation 2.014
|
|
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 5. Day 91 GMFRs
|
2.81 fold rise
Standard Deviation 2.653
|
1.10 fold rise
Standard Deviation 1.986
|
|
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Visit 6. Day 181 GMFRs
|
1.71 fold rise
Standard Deviation 2.565
|
1.55 fold rise
Standard Deviation 2.462
|
SECONDARY outcome
Timeframe: up to Day 181Population: Full analysis set
Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).
Outcome measures
| Measure |
AZD3152
n=87 Participants
AZD3152 300 mg
|
Placebo
n=29 Participants
Saline Placebo
|
|---|---|---|
|
Incidence of a Post-treatment Symptomatic COVID-19 Case
|
4 Participants
|
2 Participants
|
Adverse Events
AZD3152
Serious events: 5 serious events
Other events: 45 other events
Deaths: 2 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3152
n=87 participants at risk
AZD3152 300 mg
|
Placebo
n=29 participants at risk
Saline Placebo
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.3%
2/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
COVID-19
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Necrotising ulcerative gingivostomatitis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
100.0%
1/1 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
Other adverse events
| Measure |
AZD3152
n=87 participants at risk
AZD3152 300 mg
|
Placebo
n=29 participants at risk
Saline Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
3/87 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.3%
2/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
6.9%
2/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Eye disorders
Dry eye
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Eye disorders
Presbyopia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
General disorders
Asthenia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
General disorders
Chest pain
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
General disorders
Injection site haematoma
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Respiratory tract infection
|
10.3%
9/87 • Number of events 10 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
COVID-19
|
4.6%
4/87 • Number of events 4 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
6.9%
2/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
3/87 • Number of events 4 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
10.3%
3/29 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Pharyngitis
|
3.4%
3/87 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Acute sinusitis
|
3.4%
3/87 • Number of events 4 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Bronchitis
|
2.3%
2/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
6.9%
2/29 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Oral herpes
|
3.4%
3/87 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Rhinitis
|
3.4%
3/87 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Necrotising ulcerative gingivostomatitis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Oral candidiasis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Otosalpingitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Sinusitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Tracheitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Vaginal infection
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Infections and infestations
Varicella
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
6.9%
2/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Blood pressure increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
6.9%
2/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Blood urea increased
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cystadenoma
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Nervous system disorders
Dizziness
|
2.3%
2/87 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Nervous system disorders
Headache
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Nervous system disorders
Cerebrovascular disorder
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 2 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Renal and urinary disorders
Renal cyst
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Hypertension
|
2.3%
2/87 • Number of events 3 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Brachiocephalic arteriosclerosis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/87 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
3.4%
1/29 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Hypotension
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
|
Vascular disorders
Pelvic venous thrombosis
|
1.1%
1/87 • Number of events 1 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
0.00%
0/29 • AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place