Trial Outcomes & Findings for Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis (NCT NCT04864392)
NCT ID: NCT04864392
Last Updated: 2026-04-02
Results Overview
The cartilage thickness in the cMTFC of the target knee was assessed by quantitative Magnetic Resonance Imaging (qMRI). The change from baseline at Week 104 was calculated. A negative change from baseline indicated a reduction in the cartilage thickness
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
576 participants
Primary outcome timeframe
Baseline, Week 104
Results posted on
2026-04-02
Participant Flow
Participants were recruited from 76 centers across 16 countries. Only participants who completed the Core Period were eligible to enter the Extension Period. One participant from Arm 4 who completed the Core Period did not enter the Extension Period and is therefore not included in the Extension Period counts.
Participant milestones
| Measure |
Placebo x3, Q6m
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
Arm 3: LNA043 20 mg x3, Q6m
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
|---|---|---|---|---|---|
|
Core Period
STARTED
|
115
|
114
|
114
|
117
|
116
|
|
Core Period
COMPLETED
|
84
|
91
|
81
|
91
|
92
|
|
Core Period
NOT COMPLETED
|
31
|
23
|
33
|
26
|
24
|
|
Extension Period
STARTED
|
84
|
90
|
81
|
91
|
92
|
|
Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period
NOT COMPLETED
|
84
|
90
|
81
|
91
|
92
|
Reasons for withdrawal
| Measure |
Placebo x3, Q6m
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
Arm 3: LNA043 20 mg x3, Q6m
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
|---|---|---|---|---|---|
|
Core Period
Subject / Guardian Decision
|
19
|
15
|
14
|
13
|
10
|
|
Core Period
Adverse Event
|
4
|
3
|
10
|
6
|
8
|
|
Core Period
Lost to Follow-up
|
3
|
1
|
2
|
2
|
3
|
|
Core Period
Physician Decision
|
1
|
2
|
4
|
1
|
1
|
|
Core Period
Protocol Deviation
|
2
|
1
|
1
|
2
|
0
|
|
Core Period
Lack of Efficacy
|
0
|
0
|
2
|
2
|
1
|
|
Core Period
Death
|
1
|
1
|
0
|
0
|
1
|
|
Core Period
Technical Problems
|
1
|
0
|
0
|
0
|
0
|
|
Extension Period
Study terminated by Sponsor
|
77
|
87
|
78
|
88
|
89
|
|
Extension Period
Subject / Guardian Decision
|
4
|
1
|
2
|
1
|
1
|
|
Extension Period
Physician Decision
|
2
|
1
|
1
|
1
|
1
|
|
Extension Period
Adverse Event
|
1
|
1
|
0
|
1
|
0
|
|
Extension Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Arm 1: LNA043 40 mg x3, Q6m
n=114 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=117 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
Arm 3: LNA043 20 mg x3, Q6m
n=116 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=114 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=115 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 7.90 • n=10 Participants
|
60.9 Years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 7.64 • n=11 Participants
|
60.0 Years
STANDARD_DEVIATION 8.07 • n=13 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
71 Participants
n=5 Participants
|
74 Participants
n=10 Participants
|
65 Participants
n=5 Participants
|
80 Participants
n=11 Participants
|
354 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
46 Participants
n=5 Participants
|
42 Participants
n=10 Participants
|
49 Participants
n=5 Participants
|
35 Participants
n=11 Participants
|
222 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=5 Participants
|
80 Participants
n=5 Participants
|
86 Participants
n=10 Participants
|
94 Participants
n=5 Participants
|
96 Participants
n=11 Participants
|
438 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
16 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
18 Participants
n=10 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=11 Participants
|
89 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
31 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The cartilage thickness in the cMTFC of the target knee was assessed by quantitative Magnetic Resonance Imaging (qMRI). The change from baseline at Week 104 was calculated. A negative change from baseline indicated a reduction in the cartilage thickness
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=83 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=86 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=82 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=76 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=87 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in Cartilage Thickness in the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee at Week 104
|
-0.26716 millimiter (mm)
Standard Error 0.029124
|
-0.25722 millimiter (mm)
Standard Error 0.028816
|
-0.26719 millimiter (mm)
Standard Error 0.029518
|
-0.29068 millimiter (mm)
Standard Error 0.030098
|
-0.30318 millimiter (mm)
Standard Error 0.028962
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The WOMAC pain scale included five questions about pain during specific activities such as walking on a flat surface, going up or down stairs, during the night while in bed, sitting or lying down and standing upright. Each item was rated on an 11-point numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). The WOMAC pain subscale was calculated as the sum of the 5 pain items, ranging from 0 to 50, with higher scores indicating worse pain. Scores were then re-scaled to normalized 0-100. Change from baseline at Week 104 was assessed, where a negative change indicated improvement.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=78 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=79 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=81 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Scale at Week 104
|
-29.96 Score on a Scale
Standard Error 2.170
|
-30.46 Score on a Scale
Standard Error 2.153
|
-29.98 Score on a Scale
Standard Error 2.208
|
-27.77 Score on a Scale
Standard Error 2.226
|
-32.53 Score on a Scale
Standard Error 2.166
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The WOMAC pain scale included five questions about pain during specific activities such as walking on a flat surface, going up or down stairs, during the night while in bed, sitting or lying down and standing upright. Each item was rated on an 11-point NRS from 0 (no pain) to 10 (worst imaginable pain). Scores were then re-scaled to normalized 0-100. The change from baseline at Week 104 in WOMAC pain walking on a flat surface item score was assessed, where a negative change indicated improvement.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=78 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=79 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=81 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in WOMAC Pain Walking on a Flat Surface Item at Week 104
|
-28.09 Score on a Scale
Standard Error 2.413
|
-27.95 Score on a Scale
Standard Error 2.394
|
-28.91 Score on a Scale
Standard Error 2.462
|
-26.43 Score on a Scale
Standard Error 2.477
|
-31.09 Score on a Scale
Standard Error 2.399
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The WOMAC functional subscale included 17 questions that measured how OA affected their daily activities including going up and down stairs, sitting, standing, squatting to the floor, walking, getting in a car, shopping, putting on and taking off socks, getting out of bed, lying in bed, bathing, sitting, getting on and off the toilet, heavy domestic duties, and light domestic duties. Each item was rated on an 11-point NRS from 0 (no limitation) to 10 (extreme limitation). The WOMAC functional subscale was calculated as the sum of the 17 pain items, ranging from 0 to 170, with higher scores indicating more severe limitations. Scores were then re-scaled to normalized 0-100. Change from baseline at Week 104 was assessed, where a negative change indicated improvement.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=78 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=79 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=73 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=81 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in WOMAC Function Scale at Week 104
|
-28.09 Score on a Scale
Standard Error 2.413
|
-27.95 Score on a Scale
Standard Error 2.394
|
-28.91 Score on a Scale
Standard Error 2.462
|
-26.43 Score on a Scale
Standard Error 2.477
|
-31.09 Score on a Scale
Standard Error 2.399
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The cartilage thickness in the total TFC in the target knee was assessed by qMRI. The change from baseline at Week 104 was calculated. A negative change from baseline indicated a reduction in the cartilage thickness.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=83 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=86 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=82 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=76 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=87 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in Cartilage Thickness in the Total Tibiofemoral Compartments (TFCs) in the Target Knee at Week 104
|
-0.09345 milimiter (mm)
Standard Error 0.006231
|
-0.09619 milimiter (mm)
Standard Error 0.006151
|
-0.09912 milimiter (mm)
Standard Error 0.006288
|
-0.10038 milimiter (mm)
Standard Error 0.006428
|
-0.10412 milimiter (mm)
Standard Error 0.006157
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The cartilage thickness in the medial TFC in the target knee was assessed by qMRI at Week 104. The change from baseline at Week 104 was calculated. A negative change from baseline indicated a reduction in the cartilage thickness.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=83 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=86 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=82 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=76 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=87 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in Cartilage Thickness in the Medial TFCs in the Target Knee at Week 104
|
-0.20151 milimiter (mm)
Standard Error 0.017551
|
-0.20537 milimiter (mm)
Standard Error 0.017364
|
-0.21689 milimiter (mm)
Standard Error 0.017788
|
-0.22475 milimiter (mm)
Standard Error 0.018161
|
-0.23277 milimiter (mm)
Standard Error 0.017442
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The cartilage thickness in the lateral TFC in the target knee was assessed by qMRI at Week 104. The change from baseline at Week 104 was calculated. A negative change from baseline indicated a reduction in the cartilage thickness.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=83 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=86 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=82 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=77 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=87 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline in Cartilage Thickness in the Lateral TFCs in the Target Knee at Week 104
|
-0.14826 milimiter (mm)
Standard Error 0.012539
|
-0.16152 milimiter (mm)
Standard Error 0.012401
|
-0.14920 milimiter (mm)
Standard Error 0.012641
|
-0.15194 milimiter (mm)
Standard Error 0.012873
|
-0.16868 milimiter (mm)
Standard Error 0.012377
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The OARSI 40-meter (4x10m) fast-paced walk test assessed walking speed and functional mobility over a short distance. Participants were instructed to walk as quickly and safely as possible along a 10-meter walkway, turn around a cone, and repeat the sequence four times for a total of 40 meters. The time taken to complete the 40 meters was recorded. A shorter time indicated better performance. The change from baseline at Week 104 was assessed. A negative change from baseline indicated improvement in physical function.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=78 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=81 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=70 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=71 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=78 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 104 in the Osteoarthritis Research Society International (OARSI) Physical Performance-based Assessment: 40-meter (4×10m) Fast-paced Walk Test
|
-1.846 Seconds
Standard Error 1.6514
|
-2.219 Seconds
Standard Error 1.6248
|
-3.751 Seconds
Standard Error 1.7030
|
-0.691 Seconds
Standard Error 1.7057
|
-1.455 Seconds
Standard Error 1.6486
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
The OARSI 30-second chair stand test assessed the number of times a participant stood up from a seated position and sat back down within 30 seconds. A higher number of repetitions reflected better lower limb strength and physical function. The change from baseline was evaluated at Week 104. A positive change from baseline indicated an improvement in physical function.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=77 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=80 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=70 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=71 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=78 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 104 in the OARSI Physical Performance-based Assessments: 30-second Chair Stand Test
|
2.0 Number of Repetitions
Standard Error 0.37
|
2.1 Number of Repetitions
Standard Error 0.36
|
1.4 Number of Repetitions
Standard Error 0.38
|
2.1 Number of Repetitions
Standard Error 0.38
|
2.1 Number of Repetitions
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
This performance-based endpoint assessed submaximal aerobic capacity and functional walking ability. Participants were instructed to walk as far as possible in six minutes along a standardized, level walkway, following the guidelines of the American Thoracic Society. The total distance walked in meters was recorded. A greater distance walked indicated better physical function. The change from baseline was evaluated at Week 104. A positive change from baseline reflected an improvement in physical function.
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=78 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=81 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=69 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=70 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=78 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 104 in the OARSI Physical Performance-based Assessments: 6-minute Walking Test
|
42.0 meters
Standard Error 9.37
|
24.4 meters
Standard Error 9.33
|
24.7 meters
Standard Error 9.82
|
32.7 meters
Standard Error 9.81
|
45.9 meters
Standard Error 9.39
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with measures both at baseline and at Week 104 were included in this analysis
Percentage of participants who experienced loss of medial minimum joint space width ≥ 0.70 mm from baseline as measured by X-ray at Week 104
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=91 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=91 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=85 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=80 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=89 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Loss of Medial Minimum Joint Space Width ≥0.70 mm From Baseline at Week 104
|
14.3 Percentage of participants
Interval 8.1 to 23.6
|
9.9 Percentage of participants
Interval 4.9 to 18.4
|
12.9 Percentage of participants
Interval 6.9 to 22.4
|
10.0 Percentage of participants
Interval 4.7 to 19.3
|
9.0 Percentage of participants
Interval 4.2 to 17.4
|
SECONDARY outcome
Timeframe: From baseline up to end of study, assessed up to 3.6 yearsPopulation: All participants in the Immunogenicity prevalence set with a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample.
ADA status was categorized based on baseline and post-baseline results as follows: Subjects with ADA-negative sample at baseline: Participants with a negative ADA result at baseline. Subjects with ADA-positive sample at baseline: Participants with a positive ADA result at baseline. Subjects with ADA-positive NAb sample at baseline: Participants with a positive ADA and neutralizing antibody (NAb) result at baseline. Subjects with treatment-emergent ADA-positive: Participants with a positive ADA result post-baseline and a negative result at baseline. Subjects with treatment-emergent ADA-negative: Participants with a negative ADA result at baseline and all post-baseline samples also negative. Subjects with treatment-emergent ADA-inconclusive: Participants who did not meet any of the above definitions
Outcome measures
| Measure |
Arm 3: LNA043 20 mg x3, Q6m
n=111 Participants
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=110 Participants
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Placebo x3, Q6m
n=110 Participants
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
Arm 1: LNA043 40 mg x3, Q6m
n=109 Participants
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=111 Participants
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
ADA-negative sample at baseline
|
111 Participants
|
110 Participants
|
110 Participants
|
109 Participants
|
111 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
ADA-positive sample at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
ADA-positive NAb sample at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
Treatment emergent ADA-negative
|
110 Participants
|
108 Participants
|
110 Participants
|
105 Participants
|
110 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
Treatment emergent ADA-positive
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) Status
Treatment emergent ADA-inconclusive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1: LNA043 40 mg x3, Q6m
Serious events: 17 serious events
Other events: 69 other events
Deaths: 0 deaths
Arm 2: LNA043 40 mg x3, Q12m
Serious events: 13 serious events
Other events: 69 other events
Deaths: 0 deaths
Arm 3: LNA043 20 mg x3, Q6m
Serious events: 13 serious events
Other events: 77 other events
Deaths: 1 deaths
Arm 4: LNA043 40 mg x1, Q6m
Serious events: 11 serious events
Other events: 78 other events
Deaths: 1 deaths
Any LNA043
Serious events: 54 serious events
Other events: 293 other events
Deaths: 2 deaths
Placebo x3, Q6m
Serious events: 13 serious events
Other events: 68 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: LNA043 40 mg x3, Q6m
n=114 participants at risk
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=117 participants at risk
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
Arm 3: LNA043 20 mg x3, Q6m
n=116 participants at risk
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=114 participants at risk
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Any LNA043
n=461 participants at risk
Combined 4 LNA043 treatment groups
* Arm 1: LNA043 40 mg x3, Q6m
* Arm 2: LNA043 40 mg x3, Q12m
* Arm 3: LNA043 20 mg x3, Q6m
* Arm 4: LNA043 40 mg x1, Q6m
|
Placebo x3, Q6m
n=115 participants at risk
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Hepatobiliary disorders
Cholecystitis
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Appendicitis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Arthritis bacterial
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Bronchitis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
COVID-19
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Diverticulitis
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Retroperitoneal abscess
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
4/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondromatosis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary breast neoplasm
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.43%
2/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.86%
1/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Skin and subcutaneous tissue disorders
Schnitzler's syndrome
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Vascular disorders
Embolism venous
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.22%
1/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Vascular disorders
Hypertension
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.00%
0/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
Other adverse events
| Measure |
Arm 1: LNA043 40 mg x3, Q6m
n=114 participants at risk
Core Period: Three i.a. injections of LNA043 40 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Arm 2: LNA043 40 mg x3, Q12m
n=117 participants at risk
Core Period: Three i.a. injections of LNA043 40 mg (Q4W ×3), followed six months later by three placebo injections (Q4W ×3).
Extension Period: One i.a. injection of LNA043 40 mg every 12 months for 2 years, with a placebo injection administered six months after each LNA043 dose to maintain blinding.
|
Arm 3: LNA043 20 mg x3, Q6m
n=116 participants at risk
Core Period: Three i.a. injections of LNA043 20 mg, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 20 mg every 6 months for 2 years.
|
Arm 4: LNA043 40 mg x1, Q6m
n=114 participants at risk
Core Period: One i.a. injection of LNA043 40 mg, followed by two placebo injections (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of LNA043 40 mg every 6 months for 2 years.
|
Any LNA043
n=461 participants at risk
Combined 4 LNA043 treatment groups
* Arm 1: LNA043 40 mg x3, Q6m
* Arm 2: LNA043 40 mg x3, Q12m
* Arm 3: LNA043 20 mg x3, Q6m
* Arm 4: LNA043 40 mg x1, Q6m
|
Placebo x3, Q6m
n=115 participants at risk
Core Period: Three i.a. injections of placebo, administered once every 4 weeks (Q4W ×3), repeated every 6 months.
Extension Period: One i.a. injection of placebo every 6 months for 2 years.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
5.3%
6/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.1%
6/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.2%
6/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
20/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
13/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
18.8%
22/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
16.4%
19/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
12.3%
14/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
14.8%
68/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
12.2%
14/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
General disorders
Influenza like illness
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.0%
7/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
20/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.87%
1/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
General disorders
Injection site joint pain
|
5.3%
6/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.8%
8/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.8%
9/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.3%
6/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.3%
29/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.5%
4/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
General disorders
Injection site joint swelling
|
8.8%
10/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.7%
9/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.9%
8/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.0%
8/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.6%
35/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
COVID-19
|
23.7%
27/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
17.1%
20/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
13.8%
16/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
13.2%
15/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
16.9%
78/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
12.2%
14/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.7%
2/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.1%
7/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.3%
15/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.5%
4/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.2%
6/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
20/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.1%
7/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Infections and infestations
Urinary tract infection
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
0.85%
1/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.8%
13/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.1%
7/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Contusion
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.9%
8/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
20/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
3/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.2%
6/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.7%
17/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.7%
2/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.9%
17/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
20.5%
24/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
18.1%
21/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
24.6%
28/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
19.5%
90/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
23.5%
27/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.9%
8/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.0%
8/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.4%
25/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
11.3%
13/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.0%
7/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.4%
4/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.9%
18/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.1%
7/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.9%
18/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.5%
4/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Nervous system disorders
Headache
|
5.3%
6/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.3%
5/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.4%
5/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
4.1%
19/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.8%
9/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.88%
1/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.4%
4/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
3.5%
4/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
12/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.1%
7/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
|
Vascular disorders
Hypertension
|
1.8%
2/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.0%
7/117 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
6.0%
7/116 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
7.9%
9/114 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
5.4%
25/461 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
2.6%
3/115 • From start of treatment to end of study, assessed up to 3.6 years
The safety data presented reflects cumulative data (entire study period) from both Core and Extension Periods
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER