Trial Outcomes & Findings for AVT03 With Xgeva in Healthy Male Subjects (NCT NCT05876949)
NCT ID: NCT05876949
Last Updated: 2025-05-15
Results Overview
Samples will be collected for measurement
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
208 participants
Primary outcome timeframe
Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of study
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Experimental Arm AVT03 120mg
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm received a single 120mg dose of AVT03 as a subcutaneous injection
AVT03 was given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm received a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) was given as 1 time subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
|
Overall Study
COMPLETED
|
103
|
98
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Experimental Arm AVT03 120mg
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm received a single 120mg dose of AVT03 as a subcutaneous injection
AVT03 was given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm received a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) was given as 1 time subcutaneous injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
AVT03 With Xgeva in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Experimental Arm AVT03 120mg
n=104 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm received a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 was given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=104 Participants
Xgeva (denosumab) is the active comparator for AVT03. Subjects in this arm received a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) was given as 1 time subcutaneous injection
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 7.08 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 6.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of studyPopulation: A total of 4 participants were excluded from the PK population analyses set (1 participant in the AVT03 group and 3 participants in the Xgeva group) due to limited duration of PK data.
Samples will be collected for measurement
Outcome measures
| Measure |
Experimental Arm AVT03 120mg
n=103 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 will be given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=101 Participants
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) will be given as 1 time subcutaneous injection
|
|---|---|---|
|
Co-primary PK Endpoint Cmax: Maximum Serum Concentration
|
12761.4 ng/mL
Geometric Coefficient of Variation 34
|
12259.8 ng/mL
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of studyPopulation: A total of 4 participants were excluded from the PK population analyses set (1 participant in the AVT03 group and 3 participants in the Xgeva group) due to limited duration of PK data.\[
Samples will be collected for measurement
Outcome measures
| Measure |
Experimental Arm AVT03 120mg
n=103 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 will be given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=101 Participants
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) will be given as 1 time subcutaneous injection
|
|---|---|---|
|
Co-primary PK endpoint_AUC0-t: Area Under the Serum Concentration-time Curve up to Time t, Where t is the Last Time Point With a Concentration Above the Lower Limit of Quantitation
|
15501387.9 ng·h/mL
Geometric Coefficient of Variation 27
|
14366056.2 ng·h/mL
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of studyPopulation: A total of 4 participants were excluded from the PK population analyses set (1 participant in the AVT03 group and 3 participants in the Xgeva group) due to limited duration of PK data
Samples will be collected for measurement
Outcome measures
| Measure |
Experimental Arm AVT03 120mg
n=103 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 will be given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=101 Participants
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) will be given as 1 time subcutaneous injection
|
|---|---|---|
|
PK_ AUC0-inf: Comprised of AUC0-t and AUC Extrapolated From Time t to Time Infinity.
|
15559245.8 ng·h/mL
Geometric Coefficient of Variation 28
|
14555779.3 ng·h/mL
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Day 1(week 1) to Day 196 (week 28)]Outcome measures
| Measure |
Experimental Arm AVT03 120mg
n=104 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 will be given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=104 Participants
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) will be given as 1 time subcutaneous injection
|
|---|---|---|
|
Safety Incidence, Nature and Severity of Adverse Events.
Any TEAE
|
66 participants
|
67 participants
|
|
Safety Incidence, Nature and Severity of Adverse Events.
TESAEs
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 29, Day 57, Day 71, Day 112, Day 141, Day 196/EoSSamples will be collected for measurement
Outcome measures
| Measure |
Experimental Arm AVT03 120mg
n=104 Participants
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection
AVT03: AVT03 will be given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=104 Participants
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) will be given as 1 time subcutaneous injection
|
|---|---|---|
|
Immunogenicity Presence of ADAs and Presence of nAbs Against AVT03 and Xgeva
Binding (ADA)
|
104 Participants
|
102 Participants
|
|
Immunogenicity Presence of ADAs and Presence of nAbs Against AVT03 and Xgeva
Neutralizing Antibodies
|
41 Participants
|
43 Participants
|
Adverse Events
Experimental Arm AVT03 120mg
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Active Comparator Xgeva 120mg
Serious events: 3 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental Arm AVT03 120mg
n=104 participants at risk
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm received a single 120mg dose of AVT03 as a subcutaneous injection
AVT03 was given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=104 participants at risk
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm received a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) was given as 1 time subcutaneous injection
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Alcohol use disorder
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
Other adverse events
| Measure |
Experimental Arm AVT03 120mg
n=104 participants at risk
AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm received a single 120mg dose of AVT03 as a subcutaneous injection
AVT03 was given as 1 time subcutaneous injection
|
Active Comparator Xgeva 120mg
n=104 participants at risk
Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm received a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection
Denosumab: Xgeva (denosumab) was given as 1 time subcutaneous injection
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
5/104 • Number of events 7 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Eye disorders
Chalazion
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Eye disorders
Diplopia
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
3.8%
4/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Food poisoning
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Gastrointestinal disorders
Toothache
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Application site rash
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Asthenia
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Hyperthermia
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Influenza like illness
|
2.9%
3/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Injection site erythema
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Injection site pain
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Injection site reaction
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
3.8%
4/104 • Number of events 5 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Injection site swelling
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
General disorders
Swelling face
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Body tinea
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
COVID-19
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
3.8%
4/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
3.8%
4/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Gonococcal infection
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Influenza
|
4.8%
5/104 • Number of events 5 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
5.8%
6/104 • Number of events 6 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
11/104 • Number of events 12 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
10.6%
11/104 • Number of events 13 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Oral herpes
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Pulpitis dental
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
11/104 • Number of events 11 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
9.6%
10/104 • Number of events 10 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Viraemia
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Viral infection
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
8/104 • Number of events 8 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
4.8%
5/104 • Number of events 7 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Blood potassium increased
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Blood pressure increased
|
4.8%
5/104 • Number of events 5 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Blood triglycerides increased
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
2.9%
3/104 • Number of events 4 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Headache
|
9.6%
10/104 • Number of events 12 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
6.7%
7/104 • Number of events 8 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Sciatica
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
2.9%
3/104 • Number of events 3 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
1.9%
2/104 • Number of events 2 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Vascular disorders
Haematoma
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/104 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
0.96%
1/104 • Number of events 1 • All AEs/SAEs were recorded from the time of signing the ICF until the end of the subject's participation in the study, up to 32 weeks.
|
Additional Information
Clinical Development and Medical Lead
Alvotech Swiss AG
Phone: +41 78 659 89 89
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place