Trial Outcomes & Findings for A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants (NCT NCT05632211)
NCT ID: NCT05632211
Last Updated: 2025-05-28
Results Overview
The primary PK parameters to be compared is Cmax and AUC0-inf.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
336 participants
Primary outcome timeframe
Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.
Results posted on
2025-05-28
Participant Flow
Participant milestones
| Measure |
AVT05 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
111
|
110
|
|
Overall Study
COMPLETED
|
112
|
110
|
107
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
Reasons for withdrawal
| Measure |
AVT05 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
|
Overall Study
Other reasons
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
AVT05 50mg s.c.
n=115 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
n=111 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
n=110 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 8.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Weight
|
67.74 kilograms
STANDARD_DEVIATION 9.888 • n=5 Participants
|
67.08 kilograms
STANDARD_DEVIATION 10.286 • n=7 Participants
|
67.42 kilograms
STANDARD_DEVIATION 9.736 • n=5 Participants
|
67.42 kilograms
STANDARD_DEVIATION 9.946 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.The primary PK parameters to be compared is Cmax and AUC0-inf.
Outcome measures
| Measure |
AVT05 50mg s.c.
n=114 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
n=111 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
n=106 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi
|
3453.8 ng/mL
Geometric Coefficient of Variation 52
|
3468.6 ng/mL
Geometric Coefficient of Variation 50
|
3567.1 ng/mL
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.The primary PK parameter to be compared is AUC0-inf
Outcome measures
| Measure |
AVT05 50mg s.c.
n=114 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
n=111 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
n=106 Participants
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi
|
1423639 ng·h/mL
Geometric Coefficient of Variation 38
|
1362263 ng·h/mL
Geometric Coefficient of Variation 40
|
1414744 ng·h/mL
Geometric Coefficient of Variation 37
|
Adverse Events
AVT05 50mg s.c.
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
EU Simponi 50mg s.c.
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
US Simponi 50mg s.c.
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AVT05 50mg s.c.
n=115 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
n=111 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
n=110 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Surgical and medical procedures
Abortion induced
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
Other adverse events
| Measure |
AVT05 50mg s.c.
n=115 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05: Pre filled syringes filled with AVT05
|
EU Simponi 50mg s.c.
n=111 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
US Simponi 50mg s.c.
n=110 participants at risk
Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
Simponi: Pre filled syringes filled with Simponi
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Dental caries
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
9/115 • Number of events 11 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
11.7%
13/111 • Number of events 13 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
12.7%
14/110 • Number of events 15 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Influenza
|
5.2%
6/115 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
6.4%
7/110 • Number of events 7 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
COVID-19
|
4.3%
5/115 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/111 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/110 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Cellulitis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Furuncle
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Localised infection
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Sinusitis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Headache
|
17.4%
20/115 • Number of events 23 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
11.7%
13/111 • Number of events 14 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
18.2%
20/110 • Number of events 26 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Dizziness
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/111 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Dizziness postural
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Lethargy
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Influenza like illness
|
4.3%
5/115 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/111 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
6.4%
7/110 • Number of events 7 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Injection site erythema
|
4.3%
5/115 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/110 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Vessel puncture site bruise
|
2.6%
3/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/110 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Injection site pain
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
5.4%
6/111 • Number of events 9 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/111 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Injection site pruritus
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Catheter site related reaction
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Injection site bruising
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Pyrexia
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Chills
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Implant site pruritus
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Malaise
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Puncture site erythema
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
General disorders
Vessel puncture site phlebitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
4/115 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
5.4%
6/111 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/111 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/110 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Toothache
|
2.6%
3/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Lip blister
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
3/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
5/115 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/111 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
3/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.1%
7/115 • Number of events 7 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 5 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
3.6%
4/111 • Number of events 4 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Liver function test increased
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Investigations
White blood cell count decreased
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
2/115 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.7%
2/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Injury
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/110 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
2/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
4.5%
5/111 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
5.5%
6/110 • Number of events 6 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.6%
3/115 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/111 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
2.7%
3/110 • Number of events 3 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/111 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
1.8%
2/110 • Number of events 2 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Vascular disorders
Hot flush
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Eye disorders
Blepharitis
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Eye disorders
Eye irritation
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Eye disorders
Periorbital discomfort
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Eye disorders
Photophobia
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.90%
1/111 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.87%
1/115 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/110 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/115 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.00%
0/111 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 weeks.
|
0.91%
1/110 • Number of events 1 • From time of signing the ICF until the end of the participant's participation in the study, , approximately 15 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
Restriction type: OTHER