Trial Outcomes & Findings for Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (NCT NCT02794285)
NCT ID: NCT02794285
Last Updated: 2023-01-13
Results Overview
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years. The following AESIs were pre-defined: * Non-opportunistic serious infections * Opportunistic infections * Anaphylaxis * Malignancy * Herpes zoster * Tuberculosis (TB) (including latent TB) * Influenza * Vasculitis (non-systemic lupus erythematosus \[SLE\]) * Major cardiovascular events as according to the Cardiovascular Event Adjudication Committee.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
Up to a maximum of 1114 days
Results posted on
2023-01-13
Participant Flow
This long-term extension (LTE) study was conducted at 176 study centres in 24 countries.
The LTE population was comprised of participants who had completed the 52-week double-blind treatment period in one of the Phase III feeder studies (D3461C00004 \[NCT02446899\] or D3461C00005 \[NCT02446912\]), met all LTE eligibility criteria, and were willing to continue into the extension study.
Participant milestones
| Measure |
Randomised Anifrolumab 300 mg
Anifrolumab (300 mg) administered via an intravenous (IV) infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
257
|
112
|
111
|
67
|
|
Overall Study
COMPLETED
|
178
|
54
|
69
|
41
|
|
Overall Study
NOT COMPLETED
|
79
|
58
|
42
|
26
|
Reasons for withdrawal
| Measure |
Randomised Anifrolumab 300 mg
Anifrolumab (300 mg) administered via an intravenous (IV) infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
4
|
5
|
8
|
|
Overall Study
Condition Under Investigation Improved
|
1
|
0
|
0
|
0
|
|
Overall Study
Condition Under Investigation Worsened
|
0
|
2
|
1
|
0
|
|
Overall Study
Death
|
2
|
1
|
2
|
0
|
|
Overall Study
Development of Study-specific Withdrawal Criteria
|
1
|
0
|
0
|
1
|
|
Overall Study
Failure to Meet Randomisation Criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
10
|
6
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
3
|
1
|
|
Overall Study
Severe Non-compliance to Protocol
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
38
|
29
|
20
|
12
|
|
Overall Study
Missing
|
1
|
0
|
0
|
0
|
|
Overall Study
Due to COVID-19 Pandemic
|
7
|
2
|
4
|
0
|
|
Overall Study
Other - Not Due to COVID-19 Pandemic
|
2
|
6
|
2
|
1
|
Baseline Characteristics
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Randomised Anifrolumab 300 mg
n=257 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
n=112 Participants
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
n=111 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
n=67 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
247 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
530 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
41.4 Years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
42.2 Years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
42.4 Years
STANDARD_DEVIATION 11.70 • n=4 Participants
|
42.6 Years
STANDARD_DEVIATION 11.67 • n=21 Participants
|
|
Sex: Female, Male
Female
|
237 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
505 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
173 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
365 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
33 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
54 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
198 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
420 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 1114 daysPopulation: FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years. The following AESIs were pre-defined: * Non-opportunistic serious infections * Opportunistic infections * Anaphylaxis * Malignancy * Herpes zoster * Tuberculosis (TB) (including latent TB) * Influenza * Vasculitis (non-systemic lupus erythematosus \[SLE\]) * Major cardiovascular events as according to the Cardiovascular Event Adjudication Committee.
Outcome measures
| Measure |
Randomised Anifrolumab 300 mg
n=257 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
n=112 Participants
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
n=111 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
n=67 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)
|
11.0 Events per 100 participant years
|
9.6 Events per 100 participant years
|
12.9 Events per 100 participant years
|
12.5 Events per 100 participant years
|
PRIMARY outcome
Timeframe: Up to a maximum of 1114 daysPopulation: FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
EAIRs of SAEs are presented as event rate per 100 participant years. An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria: * Results in death * Is immediately life-threatening * Requires in-patient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * Is a congenital abnormality or birth defect * Is an important medical event that may jeopardise the participant or may require medical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Randomised Anifrolumab 300 mg
n=257 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
n=112 Participants
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
n=111 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
n=67 Participants
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
EAIRs of Serious Adverse Events (SAEs)
|
8.5 Events per 100 participant years
|
11.2 Events per 100 participant years
|
10.1 Events per 100 participant years
|
10.7 Events per 100 participant years
|
Adverse Events
Randomised Anifrolumab 300 mg
Serious events: 56 serious events
Other events: 195 other events
Deaths: 3 deaths
Placebo Feeder + Placebo LTE
Serious events: 27 serious events
Other events: 79 other events
Deaths: 1 deaths
Placebo Feeder + Anifrolumab 300 mg LTE
Serious events: 26 serious events
Other events: 81 other events
Deaths: 3 deaths
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
Serious events: 14 serious events
Other events: 53 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Randomised Anifrolumab 300 mg
n=257 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
n=112 participants at risk
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
n=111 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
n=67 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.3%
6/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.0%
2/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Renal and urinary disorders
Renal impairment
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
General disorders
Non-cardiac chest pain
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
General disorders
Chest discomfort
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
General disorders
Influenza like illness
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Herpes zoster
|
2.3%
6/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pneumonia
|
2.3%
6/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
3/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
COVID-19
|
2.0%
4/201 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/64 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.4%
2/82 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/42 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.5%
3/201 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.6%
1/64 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.7%
3/82 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/42 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pyelonephritis
|
1.2%
3/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Dengue fever
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Diverticulitis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Influenza
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Herpes zoster meningitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Parotitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Cerebral infarction
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Central nervous system lupus
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Headache
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.78%
2/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Aortic valve disease
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Bundle branch block left
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Vascular disorders
Malignant hypertension
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.39%
1/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.89%
1/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.90%
1/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
Other adverse events
| Measure |
Randomised Anifrolumab 300 mg
n=257 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (300 mg) in a feeder study.
|
Placebo Feeder + Placebo LTE
n=112 participants at risk
Placebo administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Placebo Feeder + Anifrolumab 300 mg LTE
n=111 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered placebo in a feeder study.
|
Anifrolumab 150 mg Feeder + Anifrolumab 300 mg LTE
n=67 participants at risk
Anifrolumab (300 mg) administered via an IV infusion every 4 weeks for up to 152 weeks (39 doses).
Participants were previously administered anifrolumab (150 mg) in a feeder study.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.5%
63/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
11.6%
13/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
26.1%
29/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
22.4%
15/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Urinary tract infection
|
22.2%
57/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
14.3%
16/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
16.2%
18/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
13.4%
9/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.4%
55/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
16.1%
18/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
19.8%
22/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
11.9%
8/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Bronchitis
|
16.0%
41/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
8.0%
9/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
15.3%
17/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
23.9%
16/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Sinusitis
|
9.3%
24/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
8.1%
9/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
9.0%
6/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Pharyngitis
|
7.8%
20/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
5/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
10.8%
12/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
13.4%
9/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Oral herpes
|
7.4%
19/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Herpes zoster
|
6.2%
16/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
10.8%
12/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
14.9%
10/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Latent tuberculosis
|
6.2%
16/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.5%
1/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Influenza
|
5.4%
14/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
5/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
8.1%
9/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
7.5%
5/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
7/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.2%
7/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
11.7%
13/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
3/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Psychiatric disorders
Depression
|
3.5%
9/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.0%
4/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Psychiatric disorders
Insomnia
|
3.1%
8/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
5/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
10.4%
7/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Headache
|
10.9%
28/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
9.8%
11/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.3%
7/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
14.9%
10/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Nervous system disorders
Dizziness
|
3.1%
8/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.0%
4/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Vascular disorders
Hypertension
|
5.1%
13/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
3/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
18/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
10.4%
7/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
18/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
7.2%
8/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
7.5%
5/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
12/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.2%
7/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.0%
2/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
7/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
5/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.0%
4/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
7/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.2%
7/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
0.00%
0/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
21/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
8.0%
9/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
9.9%
11/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
3/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
18/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
8.9%
10/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
10.8%
12/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
13.4%
9/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
4.7%
12/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
1.8%
2/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
7.5%
5/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.6%
17/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
7.2%
8/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.0%
2/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
11/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
5.4%
6/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
3.6%
4/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
4.5%
3/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.9%
10/257 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
2.7%
3/112 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
6.3%
7/111 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
9.0%
6/67 • Day 1 up to until follow-up visit 2 (Week 164)
FAS - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place