Trial Outcomes & Findings for An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia (NCT NCT00694109)
NCT ID: NCT00694109
Last Updated: 2016-09-09
Results Overview
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Results posted on
2016-09-09
Participant Flow
The study was conducted at 33 centers in 7 countries. A total of 144 patients were enrolled in the study. 1 patient never received study drug. 2 of the enrolled patients came from a phase 2 study and its extension and consequently had very different treatment from the other treated patients, and thus were excluded from all summary tables.
Participants who successfully completed ISIS 301012 CS5 (NCT00607373), ISIS 301012CS7 (NCT00706849), ISIS 301012CS17 (NCT00694109) or MIPO3500108 (NCT00794664) with an acceptable safety profile were eligible for study.
Participant milestones
| Measure |
Mipomersen
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Overall Study
STARTED
|
142
|
|
Overall Study
Treated
|
141
|
|
Overall Study
Consented 2 Years Additional Treatment
|
42
|
|
Overall Study
Completed Consented Length of Treatment
|
60
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Mipomersen
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Adverse Event
|
74
|
|
Overall Study
Not consent of more 2 years of treatment
|
18
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Enrolled but not treated
|
1
|
|
Overall Study
Other
|
2
|
|
Overall Study
Consented but no additional treatment
|
3
|
Baseline Characteristics
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 26 (n = 130)
|
-28.5 percent change
Interval -31.9 to -25.1
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 52 (n = 111)
|
-27 percent change
Interval -31.2 to -22.8
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 76 (n = 66)
|
-27.3 percent change
Interval -33.0 to -21.6
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 104 (n = 57)
|
-27.9 percent change
Interval -33.9 to -21.8
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 130 (n = 42)
|
-21.9 percent change
Interval -31.1 to -12.7
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 156 (n = 30)
|
-21.4 percent change
Interval -31.2 to -11.7
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 182 (n = 26)
|
-23.6 percent change
Interval -36.6 to -10.6
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 208 (n = 27)
|
-26.3 percent change
Interval -36.4 to -16.2
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
week 234 (n = 17)
|
-22.5 percent change
Interval -34.3 to -10.6
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
24 weeks post last dose (n=117)
|
1.6 percent change
Interval -2.6 to 5.9
|
PRIMARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 26 (n = 130)
|
-28.9 percent change
Interval -32.0 to -25.8
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 52 (n = 111)
|
-28.1 percent change
Interval -32.0 to -24.2
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 76 (n = 66)
|
-30.3 percent change
Interval -34.7 to -26.0
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 104 (n = 57)
|
-31.2 percent change
Interval -36.5 to -25.9
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 130 (n = 43)
|
-29.1 percent change
Interval -35.7 to -22.5
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 156 (n = 30)
|
-30.2 percent change
Interval -38.1 to -22.2
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 182 (n = 26)
|
-31.1 percent change
Interval -39.9 to -22.2
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 208 (n = 27)
|
-33.3 percent change
Interval -40.8 to -25.9
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
week 234 (n = 17)
|
-31.4 percent change
Interval -38.7 to -24.1
|
|
Percent Change From Baseline in Apolipoprotein B (Apo B)
24 weeks post last dose (n=117)
|
-3.46 percent change
Interval -6.9 to 0.0
|
PRIMARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Total Cholesterol
week 52 (n = 111)
|
-20.4 percent change
Interval -23.9 to -16.8
|
|
Percent Change From Baseline in Total Cholesterol
week 26 (n = 130)
|
-21.7 percent change
Interval -24.4 to -18.9
|
|
Percent Change From Baseline in Total Cholesterol
week 76 (n = 66)
|
-20.1 percent change
Interval -24.6 to -15.5
|
|
Percent Change From Baseline in Total Cholesterol
week 104 (n = 57)
|
-19.8 percent change
Interval -24.8 to -14.7
|
|
Percent Change From Baseline in Total Cholesterol
week 130 (n = 43)
|
-14.9 percent change
Interval -22.1 to -7.8
|
|
Percent Change From Baseline in Total Cholesterol
week 156 (n = 30)
|
-14.4 percent change
Interval -22.3 to -6.6
|
|
Percent Change From Baseline in Total Cholesterol
week 182 (n = 26)
|
-14.3 percent change
Interval -25.0 to -3.5
|
|
Percent Change From Baseline in Total Cholesterol
week 208 (n = 27)
|
-16.5 percent change
Interval -24.2 to -8.8
|
|
Percent Change From Baseline in Total Cholesterol
week 234 (n = 17)
|
-12.5 percent change
Interval -21.5 to -3.4
|
|
Percent Change From Baseline in Total Cholesterol
24 weeks post last dose (n=117)
|
1.94 percent change
Interval -1.5 to 5.4
|
PRIMARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 26 (n = 130)
|
-27.2 percent change
Interval -30.4 to -24.1
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 52 (n = 111)
|
-25.4 percent change
Interval -29.5 to -21.3
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 76 (n = 66)
|
-25 percent change
Interval -30.4 to -19.7
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 104 (n = 57)
|
-26.2 percent change
Interval -32.0 to -20.4
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 130 (n = 43)
|
-20.7 percent change
Interval -29.1 to -12.3
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 156 (n = 30)
|
-20 percent change
Interval -29.6 to -10.3
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 182 (n = 26)
|
-21.7 percent change
Interval -34.7 to -8.7
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 208 (n = 27)
|
-23.9 percent change
Interval -33.7 to -14.1
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
week 234 (n = 17)
|
-19.9 percent change
Interval -31.5 to -8.2
|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
24 weeks post last dose (n=117)
|
2.5 percent change
Interval -1.8 to 6.7
|
SECONDARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Triglycerides
week 26 (n = 130)
|
-20.1 percent change
Interval -33.1 to -1.2
|
|
Percent Change From Baseline in Triglycerides
week 52 (n = 111)
|
-7.9 percent change
Interval -31.5 to 16.9
|
|
Percent Change From Baseline in Triglycerides
week 76 (n = 66)
|
-10.2 percent change
Interval -27.7 to 13.8
|
|
Percent Change From Baseline in Triglycerides
week 104 (n = 57)
|
-12.5 percent change
Interval -37.1 to 7.2
|
|
Percent Change From Baseline in Triglycerides
week 130 (n = 43)
|
-10.9 percent change
Interval -36.0 to 10.0
|
|
Percent Change From Baseline in Triglycerides
week 156 (n = 30)
|
-10.4 percent change
Interval -23.8 to 12.7
|
|
Percent Change From Baseline in Triglycerides
week 182 (n = 26)
|
-12.9 percent change
Interval -27.4 to -1.6
|
|
Percent Change From Baseline in Triglycerides
week 208 (n = 27)
|
-13.9 percent change
Interval -40.0 to 33.0
|
|
Percent Change From Baseline in Triglycerides
week 234 (n = 17)
|
1.3 percent change
Interval -15.4 to 15.7
|
|
Percent Change From Baseline in Triglycerides
24 weeks post last dose (n=117)
|
2.1 percent change
Interval -17.2 to 27.7
|
SECONDARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Lipoprotein (a)
week 26 (n = 130)
|
-20.5 percent change
Interval -39.3 to -3.6
|
|
Percent Change From Baseline in Lipoprotein (a)
week 52 (n = 111)
|
-19 percent change
Interval -33.3 to 0.0
|
|
Percent Change From Baseline in Lipoprotein (a)
week 76 (n = 66)
|
-17.9 percent change
Interval -33.3 to -0.5
|
|
Percent Change From Baseline in Lipoprotein (a)
week 104 (n = 57)
|
-16.6 percent change
Interval -36.1 to 0.0
|
|
Percent Change From Baseline in Lipoprotein (a)
week 130 (n = 43)
|
-15.8 percent change
Interval -31.3 to 0.0
|
|
Percent Change From Baseline in Lipoprotein (a)
week 156 (n = 30)
|
-9.1 percent change
Interval -33.8 to 7.3
|
|
Percent Change From Baseline in Lipoprotein (a)
week 182 (n = 26)
|
-9 percent change
Interval -27.2 to 7.6
|
|
Percent Change From Baseline in Lipoprotein (a)
week 208 (n = 27)
|
-9.9 percent change
Interval -32.5 to 4.1
|
|
Percent Change From Baseline in Lipoprotein (a)
week 234 (n = 17)
|
-18.3 percent change
Interval -31.6 to -4.8
|
|
Percent Change From Baseline in Lipoprotein (a)
24 weeks post last dose (n=117)
|
0 percent change
Interval -6.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in LDL Particles' Size (Total)
week 52 (n = 91)
|
-26.77 percent change
Interval -32.7 to -20.8
|
|
Percent Change From Baseline in LDL Particles' Size (Total)
week 104 (n = 47)
|
-27.77 percent change
Interval -35.3 to -20.3
|
|
Percent Change From Baseline in LDL Particles' Size (Total)
week 156 (n = 20)
|
-25.1 percent change
Interval -40.3 to -9.9
|
|
Percent Change From Baseline in LDL Particles' Size (Total)
week 208 (n = 19)
|
-32.65 percent change
Interval -44.9 to -20.4
|
|
Percent Change From Baseline in LDL Particles' Size (Total)
End of treatment (n=139)
|
-22.63 percent change
Interval -27.0 to -18.3
|
|
Percent Change From Baseline in LDL Particles' Size (Total)
24 weeks post last dose (n=115)
|
6.11 percent change
Interval 0.8 to 11.5
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in LDL Particles' Size (Large)
week 52 (n = 91)
|
-5.01 percent change
Interval -16.8 to 6.8
|
|
Percent Change From Baseline in LDL Particles' Size (Large)
week 104 (n = 47)
|
-14.32 percent change
Interval -27.0 to -1.6
|
|
Percent Change From Baseline in LDL Particles' Size (Large)
week 156 (n = 20)
|
-27.04 percent change
Interval -40.6 to -13.4
|
|
Percent Change From Baseline in LDL Particles' Size (Large)
week 208 (n = 19)
|
-22.67 percent change
Interval -41.6 to -3.8
|
|
Percent Change From Baseline in LDL Particles' Size (Large)
End of treatment (n=139)
|
-2.94 percent change
Interval -13.2 to 7.3
|
|
Percent Change From Baseline in LDL Particles' Size (Large)
24 weeks post last dose (n=115)
|
6.19 percent change
Interval -6.1 to 18.5
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
week 52 (n = 91)
|
-9.50 percent change
Interval -31.8 to 12.8
|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
week 104 (n = 47)
|
11.09 percent change
Interval -42.2 to 64.4
|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
week 156 (n = 20)
|
-19.62 percent change
Interval -57.3 to 18.0
|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
week 208 (n = 19)
|
-15.82 percent change
Interval -62.0 to 30.4
|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
End of treatment (n=139)
|
-5.65 percent change
Interval -30.3 to 19.0
|
|
Percent Change From Baseline in LDL Particles' Size (Medium)
24 weeks post last dose (n=115)
|
46.92 percent change
Interval 5.6 to 88.2
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in LDL Particles' Size (Small)
week 52 (n = 91)
|
-8.79 percent change
Interval -33.7 to 16.2
|
|
Percent Change From Baseline in LDL Particles' Size (Small)
week 104 (n = 47)
|
1.72 percent change
Interval -43.9 to 47.4
|
|
Percent Change From Baseline in LDL Particles' Size (Small)
week 156 (n = 20)
|
-18.95 percent change
Interval -58.8 to 20.9
|
|
Percent Change From Baseline in LDL Particles' Size (Small)
week 208 (n = 19)
|
-27.95 percent change
Interval -67.9 to 12.0
|
|
Percent Change From Baseline in LDL Particles' Size (Small)
End of treatment (n=139)
|
-5.17 percent change
Interval -29.2 to 18.8
|
|
Percent Change From Baseline in LDL Particles' Size (Small)
24 weeks post last dose (n=115)
|
51.94 percent change
Interval 7.7 to 96.2
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
week 52 (n = 91)
|
-5.05 percent change
Interval -32.2 to 22.2
|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
week 104 (n = 47)
|
-0.11 percent change
Interval -44.4 to 44.2
|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
week 156 (n = 20)
|
-18.7 percent change
Interval -59.2 to 21.8
|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
week 208 (n = 19)
|
-30.77 percent change
Interval -69.3 to 7.8
|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
End of treatment (n=139)
|
0.75 percent change
Interval -28.0 to 29.5
|
|
Percent Change From Baseline in LDL Particles' Size (Very Small)
24 weeks post last dose (n=115)
|
60.22 percent change
Interval 7.5 to 112.9
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in HDL Particles' Size (Large)
week 52 (n = 89)
|
160.8 percent change
Interval -38.3 to 359.9
|
|
Percent Change From Baseline in HDL Particles' Size (Large)
week 104 (n = 47)
|
43.23 percent change
Interval -12.2 to 98.7
|
|
Percent Change From Baseline in HDL Particles' Size (Large)
week 156 (n = 20)
|
58.26 percent change
Interval -38.0 to 154.6
|
|
Percent Change From Baseline in HDL Particles' Size (Large)
week 208 (n = 19)
|
61.76 percent change
Interval -41.6 to 165.2
|
|
Percent Change From Baseline in HDL Particles' Size (Large)
End of treatment (n=134)
|
121.16 percent change
Interval -17.3 to 259.6
|
|
Percent Change From Baseline in HDL Particles' Size (Large)
24 weeks post last dose (n=110)
|
85.93 percent change
Interval -7.3 to 179.1
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
week 208 (n = 8)
|
838.32 percent change
Interval -1109.3 to 2785.9
|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
End of treatment (n= 68)
|
388.16 percent change
Interval 94.5 to 681.8
|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
24 weeks post last dose (n=56)
|
233.78 percent change
Interval 7.9 to 459.7
|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
week 52 (n = 44)
|
154.77 percent change
Interval 2.8 to 306.8
|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
week 104 (n = 28)
|
176.14 percent change
Interval -68.6 to 420.9
|
|
Percent Change From Baseline in HDL Particles' Size (Medium)
week 156 (n = 9)
|
21.24 percent change
Interval -65.1 to 107.6
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in HDL Particles' Size (Small)
week 52 (n = 91)
|
1.83 percent change
Interval -7.3 to 10.9
|
|
Percent Change From Baseline in HDL Particles' Size (Small)
week 104 (n = 47)
|
-9.81 percent change
Interval -17.7 to -2.0
|
|
Percent Change From Baseline in HDL Particles' Size (Small)
week 156 (n = 20)
|
-14.18 percent change
Interval -25.1 to -3.2
|
|
Percent Change From Baseline in HDL Particles' Size (Small)
week 208 (n = 19)
|
-11.47 percent change
Interval -20.0 to -2.9
|
|
Percent Change From Baseline in HDL Particles' Size (Small)
End of treatment (n= 139)
|
0.44 percent change
Interval -6.9 to 7.7
|
|
Percent Change From Baseline in HDL Particles' Size (Small)
24 weeks post last dose (n=115)
|
8.31 percent change
Interval 0.6 to 16.0
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
week 52 (n = 79)
|
-9.9 percent change
Interval -45.6 to 25.8
|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
week 104 (n = 40)
|
-27.35 percent change
Interval -66.5 to 11.8
|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
week 156 (n = 16)
|
155.42 percent change
Interval -90.1 to 401.0
|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
week 208 (n = 15)
|
32.88 percent change
Interval -104.0 to 169.8
|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
End of treatment (n= 122)
|
24.66 percent change
Interval -28.4 to 77.8
|
|
Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
24 weeks post last dose (n=101)
|
57.46 percent change
Interval 15.2 to 99.8
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
week 52 (n = 86)
|
109.23 percent change
Interval 33.7 to 184.8
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
week 104 (n = 46)
|
107.5 percent change
Interval -10.2 to 225.2
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
week 156 (n = 19)
|
123.42 percent change
Interval -113.0 to 359.8
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
week 208 (n = 18)
|
241.76 percent change
Interval -241.5 to 725.1
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
End of treatment (n= 132)
|
86.75 percent change
Interval 28.4 to 145.1
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
24 weeks post last dose (n=110)
|
90.82 percent change
Interval 21.8 to 159.9
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
week 52 (n = 88)
|
70.81 percent change
Interval 2.1 to 139.5
|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
week 104 (n = 47)
|
97.74 percent change
Interval -21.0 to 216.5
|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
week 156 (n = 20)
|
172.46 percent change
Interval 5.3 to 339.7
|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
week 208 (n = 19)
|
98.7 percent change
Interval -71.3 to 268.7
|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
End of treatment (n= 136)
|
63.25 percent change
Interval 12.1 to 114.4
|
|
Percent Change From Baseline in VLDL Particles' Size (Medium)
24 weeks post last dose (n=113)
|
99.57 percent change
Interval 16.8 to 182.3
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
week 52 (n = 91)
|
49.51 percent change
Interval -41.1 to 140.4
|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
week 104 (n = 47)
|
30.48 percent change
Interval -75.1 to 136.1
|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
week 156 (n = 20)
|
9.34 percent change
Interval -48.3 to 67.0
|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
week 208 (n = 19)
|
-30.36 percent change
Interval -49.8 to -10.9
|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
End of treatment (n= 139)
|
31.27 percent change
Interval -27.3 to 89.8
|
|
Percent Change From Baseline in VLDL Particles' Size (Small)
24 weeks post last dose (n=115)
|
32.14 percent change
Interval -5.3 to 69.6
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=140 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
week 52 (n = 91)
|
19.94 percent change
Interval -36.7 to 74.6
|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
week 104 (n = 47)
|
-14.25 percent change
Interval -36.4 to 7.9
|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
week 156 (n = 20)
|
3.48 percent change
Interval -27.5 to 34.5
|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
week 208 (n = 19)
|
-18.66 percent change
Interval -43.6 to 6.3
|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
End of treatment (n= 139)
|
12.82 percent change
Interval -25.5 to 51.2
|
|
Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
24 weeks post last dose (n=115)
|
19.69 percent change
Interval 3.2 to 36.1
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Change From Baseline in C-Reactive Protein
week 26 (n=130)
|
0.67 percent change
Interval -0.8 to 2.1
|
|
Change From Baseline in C-Reactive Protein
week 52 (n=111)
|
-0.37 percent change
Interval -1.4 to 0.6
|
|
Change From Baseline in C-Reactive Protein
week 76 (n=84)
|
-1.05 percent change
Interval -2.0 to -0.1
|
|
Change From Baseline in C-Reactive Protein
week 104 (n=58)
|
0.12 percent change
Interval -0.8 to 1.0
|
|
Change From Baseline in C-Reactive Protein
week 130 (n=42)
|
-0.18 percent change
Interval -1.1 to 0.8
|
|
Change From Baseline in C-Reactive Protein
week 156 (n=30)
|
0.02 percent change
Interval -0.5 to 2.1
|
|
Change From Baseline in C-Reactive Protein
week 182 (n=31)
|
0.73 percent change
Interval 0.1 to 1.4
|
|
Change From Baseline in C-Reactive Protein
week 208 (n=27)
|
0.2 percent change
Interval -0.5 to 0.9
|
|
Change From Baseline in C-Reactive Protein
week 234 (n=18)
|
0.53 percent change
Interval -0.5 to 1.5
|
|
Change From Baseline in C-Reactive Protein
End of treatment (n=140)
|
0.41 percent change
Interval -0.6 to 1.4
|
|
Change From Baseline in C-Reactive Protein
24 weeks post last dose (n=116)
|
0.09 percent change
Interval -0.9 to 1.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)Population: Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \<6 months from their last dose of mipomersen in their index study).
Outcome measures
| Measure |
Mipomersen
n=141 Participants
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Percent Change From Baseline in Apolipoprotein A-1
week 26 (n=130)
|
-1.01 percent change
Interval -3.8 to 1.7
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 52 (n=111)
|
-1.59 percent change
Interval -4.7 to 1.6
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 76 (n=66)
|
-3.73 percent change
Interval -7.9 to 0.5
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 104 (n=57)
|
-4.33 percent change
Interval -9.1 to 0.4
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 130 (n=43)
|
-1.37 percent change
Interval -6.1 to 3.4
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 156 (n=30)
|
-5.55 percent change
Interval -11.2 to 0.0
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 182 (n=26)
|
-3.17 percent change
Interval -9.4 to 3.1
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 208 (n=27)
|
-2.19 percent change
Interval -7.2 to 2.8
|
|
Percent Change From Baseline in Apolipoprotein A-1
week 234 (n=17)
|
3.68 percent change
Interval -3.0 to 10.3
|
|
Percent Change From Baseline in Apolipoprotein A-1
24 weeks post last dose (n = 117)
|
-0.67 percent change
Interval -3.5 to 2.2
|
Adverse Events
Mipomersen
Serious events: 36 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mipomersen
n=141 participants at risk
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Angina pectoris
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Angina unstable
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Aortic valve stenosis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Coronary artery disease
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Myocardial infarction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Chest pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Device malfunction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Non-cardiac chest pain
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Pyrexia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Biliary colic
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Immune system disorders
Contrast media allergy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Appendicitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Influenza
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Amnesia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Arachnoid cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Partial seizures
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Syncope
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Alcoholism
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Surgical and medical procedures
Ileostomy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic aneurysm
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic stenosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Femoral artery occlusion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Peripheral artery dissection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
Other adverse events
| Measure |
Mipomersen
n=141 participants at risk
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed \<50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Constipation
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
21/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Diverticulum
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Angina pectoris
|
9.9%
14/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Aortic valve disease
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Bradycardia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Extrasystoles
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Palpitations
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Tachycardia
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Ventricular dysfunction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Endocrine disorders
Hypothyroidism
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Arcus lipoides
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Cataract
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Diplopia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Dry eye
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Eye irritation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Eye pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Eye swelling
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Eyelid cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Halo vision
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Ocular hyperaemia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Presbyopia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Vision blurred
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Eye disorders
Vitreous floaters
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
9.9%
14/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
7/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Bezoar
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Faeces soft
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Flatulence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Food poisoning
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Gingival recession
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Haematochezia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Lip blister
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Lip swelling
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Nausea
|
26.2%
37/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Odynophagia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Retching
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Tooth impacted
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Toothache
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
13/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Asthenia
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Chest discomfort
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Chest pain
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Chills
|
19.1%
27/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Cyst
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Device breakage
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Device failure
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Discomfort
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Exercise tolerance decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Facial pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Fatigue
|
27.0%
38/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Feeling cold
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Gait disturbance
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Influenza like illness
|
49.6%
70/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site atrophy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site bruising
|
51.1%
72/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site discolouration
|
39.0%
55/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site discomfort
|
9.9%
14/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site eczema
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site erythema
|
83.0%
117/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site exfoliation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site extravasation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site haematoma
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site haemorrhage
|
12.1%
17/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site hypersensitivity
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site hypertrophy
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site hypoaesthesia
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site induration
|
22.0%
31/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site inflammation
|
8.5%
12/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site lymphadenopathy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site macule
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site mass
|
9.9%
14/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site nodule
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site oedema
|
13.5%
19/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site pain
|
72.3%
102/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site pallor
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site papule
|
5.0%
7/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site paraesthesia
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site pruritus
|
32.6%
46/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site rash
|
11.3%
16/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site reaction
|
8.5%
12/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site recall reaction
|
7.1%
10/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site swelling
|
22.0%
31/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site urticaria
|
7.1%
10/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site vesicles
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Injection site warmth
|
13.5%
19/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Local swelling
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Localised oedema
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Malaise
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Non-cardiac chest pain
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Oedema peripheral
|
7.1%
10/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Pain
|
9.2%
13/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Pyrexia
|
17.7%
25/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Swelling
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Temperature intolerance
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Tenderness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Vaccination site pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Vessel puncture site bruise
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
General disorders
Xerosis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Biliary cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
12.1%
17/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Hepatobiliary disorders
Hepatomegaly
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Immune system disorders
Hypersensitivity
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Immune system disorders
Seasonal allergy
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Immune system disorders
Serum sickness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Abscess limb
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Acarodermatitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Acute sinusitis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Anal abscess
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Bronchitis
|
7.1%
10/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Bronchopneumonia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Cellulitis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Conjunctivitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Cystitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Diverticulitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Ear infection
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Eye infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Folliculitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Furuncle
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Gastroenteritis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Gastroenteritis viral
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Gastrointestinal infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Gastrointestinal viral infection
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Genital herpes simplex
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Giardiasis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
H1N1 influenza
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Helicobacter gastritis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Herpes zoster
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Influenza
|
12.1%
17/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Kidney infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Laryngitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Localised infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Nasopharyngitis
|
19.9%
28/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Onychomycosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Oral herpes
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Otitis externa
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Otitis media acute
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Paronychia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Pharyngitis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Pneumonia
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Post procedural infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Rhinitis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Sinobronchitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Sinusitis
|
14.2%
20/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Skin bacterial infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Tinea cruris
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Tinea versicolour
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Tooth abscess
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Tooth infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
19.1%
27/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Urinary tract infection
|
16.3%
23/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Vaginal infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Viral infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Wound infection
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Infections and infestations
Wound sepsis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Back injury
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Contusion
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Injury
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
7/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Injury, poisoning and procedural complications
Wound
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Alanine aminotransferase increased
|
18.4%
26/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Albumin urine present
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
21/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Beta 2 microglobulin urine increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood bicarbonate decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood creatinine increased
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood phosphorus decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood potassium increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood pressure increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood testosterone decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Blood uric acid increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Body temperature increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
C-reactive protein increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Cardiac murmur
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Carotid bruit
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Electrocardiogram ST segment depression
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Electrocardiogram T wave inversion
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Electrocardiogram abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Haematocrit decreased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Haemoglobin decreased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Heart rate increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Hepatic enzyme increased
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
International normalised ratio increased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Liver function test abnormal
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Liver scan abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Lymph node palpable
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Lymphocyte count decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Multiple gated acquisition scan abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Peripheral pulse decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Platelet count decreased
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Protein urine present
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Prothrombin time prolonged
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Red blood cell acanthocytes present
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Red blood cell count decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Red blood cell schistocytes present
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Red blood cells urine positive
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Scan myocardial perfusion abnormal
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Transaminases increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Urine analysis abnormal
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Weight decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
Weight increased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Investigations
White blood cell count decreased
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Gout
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
19/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.0%
24/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
7/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.4%
33/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
14/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue atrophy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
3.5%
5/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Burning sensation
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Cluster headache
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Cognitive disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Dizziness
|
7.1%
10/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Dizziness postural
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Dysgeusia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Headache
|
24.8%
35/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
7/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Lethargy
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Loss of consciousness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Migraine
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Migraine with aura
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Morton's neuralgia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Nerve compression
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Neuralgia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Orthostatic intolerance
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Paraesthesia
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Presyncope
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Restless legs syndrome
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Sciatica
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Sinus headache
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Somnolence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Syncope
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
Tremor
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Abnormal sleep-related event
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Anxiety
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Confusional state
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Depression
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Insomnia
|
6.4%
9/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Libido decreased
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Panic attack
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Psychiatric disorders
Stress
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Albuminuria
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Bladder discomfort
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Dysuria
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Haematuria
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Micturition urgency
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Nephropathy
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Pyuria
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Renal cyst
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Renal failure
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Urge incontinence
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Breast mass
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
15/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
12/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.2%
13/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Macule
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
6/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic aneurysm
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic calcification
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic dilatation
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Aortic stenosis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Flushing
|
2.1%
3/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Haematoma
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Hot flush
|
2.8%
4/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Hypertension
|
5.7%
8/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Hypertensive crisis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Hypotension
|
1.4%
2/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Infarction
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Intermittent claudication
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Orthostatic hypotension
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Pallor
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Peripheral coldness
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
|
Vascular disorders
Phlebitis
|
0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
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Vascular disorders
Subclavian artery stenosis
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0.71%
1/141 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the start of study drug in this study up to 24 weeks post-treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER