Trial Outcomes & Findings for A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus (NCT NCT05123586)
NCT ID: NCT05123586
Last Updated: 2025-01-20
Results Overview
Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Week 24
Results posted on
2025-01-20
Participant Flow
Participant milestones
| Measure |
450 Milligrams (mg) - LY3361237
Participants received 450 mg of LY3361237 administered subcutaneously (SC) every 2 weeks (Q2W) along with their usual Standard of Care (SOC) medication for 24 weeks.
|
Placebo
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
42
|
43
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
450 Milligrams (mg) - LY3361237
Participants received 450 mg of LY3361237 administered subcutaneously (SC) every 2 weeks (Q2W) along with their usual Standard of Care (SOC) medication for 24 weeks.
|
Placebo
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
450 mg - LY3361237
n=42 Participants
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 Participants
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All participants who received at least 1 dose of study drug and had evaluable data for this outcome.
Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Outcome measures
| Measure |
450 mg - LY3361237
n=42 Participants
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 Participants
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash
|
11.9 Percentage of participants
|
20.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants who received at least 1 dose of the study drug and had evaluable data for this outcome.
Percentage of participants who achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Outcome measures
| Measure |
450 mg - LY3361237
n=42 Participants
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 Participants
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response
|
9.5 Percentage of participants
|
16.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants who received at least 1 dose of study drug and have evaluable data for this outcome.
Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
450 mg - LY3361237
n=42 Participants
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 Participants
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)
|
9.5 Percentage of participants
|
16.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants who received at least one dose of LY3361237 and had evaluable PK data for this outcome.
PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed.
Outcome measures
| Measure |
450 mg - LY3361237
n=21 Participants
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24
|
144 micrograms per milliliter (μg/mL)
Standard Deviation 73.8
|
—
|
Adverse Events
450 mg - LY3361237
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
450 mg - LY3361237
n=42 participants at risk
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 participants at risk
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diplopia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood glucose abnormal
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
450 mg - LY3361237
n=42 participants at risk
Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.
|
Placebo
n=43 participants at risk
Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
7.1%
3/42 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
4.8%
2/42 • Number of events 6 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
11.9%
5/42 • Number of events 14 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site haemorrhage
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site oedema
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
14.3%
6/42 • Number of events 97 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.0%
3/43 • Number of events 32 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
4.8%
2/42 • Number of events 21 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial disease carrier
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/38 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
7.1%
3/42 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Candida infection
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
9.5%
4/42 • Number of events 4 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.0%
3/43 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
7.1%
3/42 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Mycoplasma infection
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
7.1%
3/42 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis media acute
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis bacterial
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
2/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
3/42 • Number of events 3 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.3%
4/43 • Number of events 5 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
4/42 • Number of events 5 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.0%
6/43 • Number of events 6 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/38 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginitis
|
2.6%
1/38 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Cardiolipin antibody positive
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • Number of events 9 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
2/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
2.6%
1/38 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
2/43 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
2/42 • Number of events 2 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/38 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/42 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/43 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
2.4%
1/42 • Number of events 1 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/43 • Baseline Up To 25 Weeks
All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60