Trial Outcomes & Findings for Study of ARO-ANG3 in Adults With Mixed Dyslipidemia (NCT NCT04832971)
NCT ID: NCT04832971
Last Updated: 2025-12-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment Period
STARTED
|
51
|
51
|
51
|
51
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment Period
COMPLETED
|
48
|
46
|
47
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment Period
NOT COMPLETED
|
3
|
5
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
STARTED
|
0
|
0
|
0
|
0
|
13
|
36
|
14
|
39
|
13
|
41
|
|
Open-Label Extension (OLE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
17
|
3
|
14
|
6
|
17
|
|
Open-Label Extension (OLE) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
8
|
19
|
11
|
25
|
7
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment Period
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment Period
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment Period
Withdrawal by Subject
|
1
|
3
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment Period
Other, Not Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
1
|
|
Open-Label Extension (OLE) Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
7
|
18
|
7
|
19
|
4
|
19
|
|
Open-Label Extension (OLE) Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
2
|
3
|
|
Open-Label Extension (OLE) Period
Other, Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
13 Participants
n=205 Participants
|
55 Participants
n=16 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.30 • n=9 Participants
|
60.4 years
STANDARD_DEVIATION 12.68 • n=6 Participants
|
60.0 years
STANDARD_DEVIATION 9.89 • n=9 Participants
|
61.5 years
STANDARD_DEVIATION 12.53 • n=205 Participants
|
60.5 years
STANDARD_DEVIATION 11.58 • n=16 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
25 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
24 Participants
n=205 Participants
|
95 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
27 Participants
n=205 Participants
|
109 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=9 Participants
|
39 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
38 Participants
n=205 Participants
|
149 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=9 Participants
|
49 Participants
n=6 Participants
|
49 Participants
n=9 Participants
|
49 Participants
n=205 Participants
|
195 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
|
Mean Triglycerides (TG) at Baseline
|
235.15 mg/dL
STANDARD_DEVIATION 86.117 • n=9 Participants
|
242.47 mg/dL
STANDARD_DEVIATION 79.864 • n=6 Participants
|
246.71 mg/dL
STANDARD_DEVIATION 97.996 • n=9 Participants
|
259.97 mg/dL
STANDARD_DEVIATION 93.320 • n=205 Participants
|
246.08 mg/dL
STANDARD_DEVIATION 89.386 • n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of investigational product (IP) during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=47 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=49 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=47 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=47 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting TG at Week 24
|
-49.01 percentage change
Standard Error 3.777
|
-55.57 percentage change
Standard Error 3.726
|
7.55 percentage change
Standard Error 3.774
|
-43.67 percentage change
Standard Error 3.770
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting TG Over Time
Week 4
|
-52.22 percentage change
Standard Error 3.658
|
-56.21 percentage change
Standard Error 3.619
|
7.00 percentage change
Standard Error 3.583
|
-41.52 percentage change
Standard Error 3.604
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 8
|
-47.73 percentage change
Standard Error 4.250
|
-52.55 percentage change
Standard Error 4.257
|
13.58 percentage change
Standard Error 4.188
|
-41.01 percentage change
Standard Error 4.217
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 12
|
-41.71 percentage change
Standard Error 4.274
|
-49.84 percentage change
Standard Error 4.183
|
2.17 percentage change
Standard Error 4.305
|
-42.79 percentage change
Standard Error 4.269
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 16
|
-51.99 percentage change
Standard Error 6.942
|
-58.73 percentage change
Standard Error 6.820
|
17.18 percentage change
Standard Error 6.952
|
-48.48 percentage change
Standard Error 6.947
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 20
|
-52.73 percentage change
Standard Error 5.942
|
-57.97 percentage change
Standard Error 5.790
|
11.54 percentage change
Standard Error 5.930
|
-48.70 percentage change
Standard Error 5.928
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 24
|
-49.01 percentage change
Standard Error 3.777
|
-55.57 percentage change
Standard Error 3.726
|
7.55 percentage change
Standard Error 3.774
|
-43.67 percentage change
Standard Error 3.770
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 28
|
-43.95 percentage change
Standard Error 4.039
|
-54.39 percentage change
Standard Error 3.920
|
7.24 percentage change
Standard Error 3.950
|
-41.38 percentage change
Standard Error 3.966
|
—
|
—
|
|
Percent Change From Baseline in Fasting TG Over Time
Week 36
|
-38.33 percentage change
Standard Error 3.850
|
-51.63 percentage change
Standard Error 3.750
|
-0.43 percentage change
Standard Error 3.798
|
-34.49 percentage change
Standard Error 3.809
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=47 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=49 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=47 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=47 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
|
-24.6 percentage change
Standard Error 3.31
|
-32.2 percentage change
Standard Error 3.26
|
4.2 percentage change
Standard Error 3.31
|
-25.1 percentage change
Standard Error 3.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 4
|
-25.3 percentage change
Standard Error 2.55
|
-32.9 percentage change
Standard Error 2.50
|
5.2 percentage change
Standard Error 2.51
|
-23.5 percentage change
Standard Error 2.52
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 8
|
-22.8 percentage change
Standard Error 3.04
|
-30.3 percentage change
Standard Error 3.02
|
3.7 percentage change
Standard Error 3.02
|
-24.4 percentage change
Standard Error 3.04
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 12
|
-18.4 percentage change
Standard Error 3.04
|
-28.1 percentage change
Standard Error 2.97
|
3.4 percentage change
Standard Error 3.06
|
-22.8 percentage change
Standard Error 3.04
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 16
|
-28.3 percentage change
Standard Error 2.85
|
-37.0 percentage change
Standard Error 2.81
|
2.5 percentage change
Standard Error 2.86
|
-26.8 percentage change
Standard Error 2.86
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 20
|
-26.5 percentage change
Standard Error 2.69
|
-34.1 percentage change
Standard Error 2.64
|
0.8 percentage change
Standard Error 2.71
|
-28.1 percentage change
Standard Error 2.70
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 24
|
-24.6 percentage change
Standard Error 3.31
|
-32.2 percentage change
Standard Error 3.26
|
4.2 percentage change
Standard Error 3.31
|
-25.1 percentage change
Standard Error 3.31
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 28
|
-22.3 percentage change
Standard Error 3.04
|
-30.0 percentage change
Standard Error 2.96
|
1.2 percentage change
Standard Error 3.00
|
-23.1 percentage change
Standard Error 3.01
|
—
|
—
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Week 36
|
-17.3 percentage change
Standard Error 3.23
|
-24.1 percentage change
Standard Error 3.14
|
-1.5 percentage change
Standard Error 3.19
|
-20.2 percentage change
Standard Error 3.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=46 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=48 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=46 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=46 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
|
-12.91 percentage change
Standard Error 2.805
|
-19.64 percentage change
Standard Error 2.788
|
2.27 percentage change
Standard Error 2.807
|
-16.40 percentage change
Standard Error 2.835
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 4
|
-11.71 percentage change
Standard Error 2.093
|
-18.47 percentage change
Standard Error 2.105
|
2.57 percentage change
Standard Error 2.074
|
-14.00 percentage change
Standard Error 2.116
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 8
|
-10.66 percentage change
Standard Error 2.525
|
-15.05 percentage change
Standard Error 2.556
|
1.51 percentage change
Standard Error 2.518
|
-15.85 percentage change
Standard Error 2.553
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 12
|
-7.69 percentage change
Standard Error 2.617
|
-15.10 percentage change
Standard Error 2.606
|
2.26 percentage change
Standard Error 2.656
|
-14.96 percentage change
Standard Error 2.653
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 16
|
-14.33 percentage change
Standard Error 2.513
|
-21.66 percentage change
Standard Error 2.509
|
-1.36 percentage change
Standard Error 2.524
|
-15.72 percentage change
Standard Error 2.543
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 20
|
-14.52 percentage change
Standard Error 2.329
|
-18.58 percentage change
Standard Error 2.326
|
-0.28 percentage change
Standard Error 2.350
|
-17.99 percentage change
Standard Error 2.370
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 24
|
-12.91 percentage change
Standard Error 2.805
|
-19.64 percentage change
Standard Error 2.788
|
2.27 percentage change
Standard Error 2.807
|
-16.40 percentage change
Standard Error 2.835
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 28
|
-12.47 percentage change
Standard Error 2.703
|
-17.03 percentage change
Standard Error 2.680
|
0.51 percentage change
Standard Error 2.688
|
-15.39 percentage change
Standard Error 2.725
|
—
|
—
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time
Week 36
|
-9.07 percentage change
Standard Error 2.791
|
-13.21 percentage change
Standard Error 2.756
|
-2.30 percentage change
Standard Error 2.777
|
-12.85 percentage change
Standard Error 2.801
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=47 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=49 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=47 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=47 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
|
-4.3 percentage change
Standard Error 4.56
|
-15.1 percentage change
Standard Error 4.51
|
5.0 percentage change
Standard Error 4.53
|
-11.0 percentage change
Standard Error 4.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 4
|
-3.4 percentage change
Standard Error 4.02
|
-13.7 percentage change
Standard Error 3.98
|
5.1 percentage change
Standard Error 3.95
|
-8.3 percentage change
Standard Error 4.03
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 8
|
-0.7 percentage change
Standard Error 4.83
|
-10.8 percentage change
Standard Error 4.81
|
3.7 percentage change
Standard Error 4.78
|
-10.1 percentage change
Standard Error 4.85
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 12
|
7.9 percentage change
Standard Error 7.34
|
-12.1 percentage change
Standard Error 7.23
|
7.7 percentage change
Standard Error 7.31
|
-7.6 percentage change
Standard Error 7.36
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 16
|
-7.4 percentage change
Standard Error 4.52
|
-19.5 percentage change
Standard Error 4.48
|
3.6 percentage change
Standard Error 4.51
|
-9.5 percentage change
Standard Error 4.56
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 20
|
-6.9 percentage change
Standard Error 4.28
|
-15.3 percentage change
Standard Error 4.22
|
1.8 percentage change
Standard Error 4.26
|
-12.2 percentage change
Standard Error 4.31
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 24
|
-4.3 percentage change
Standard Error 4.56
|
-15.1 percentage change
Standard Error 4.51
|
5.0 percentage change
Standard Error 4.53
|
-11.0 percentage change
Standard Error 4.58
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 28
|
-2.4 percentage change
Standard Error 4.74
|
-11.3 percentage change
Standard Error 4.66
|
0.2 percentage change
Standard Error 4.67
|
-9.1 percentage change
Standard Error 4.75
|
—
|
—
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Week 36
|
3.7 percentage change
Standard Error 5.82
|
-4.4 percentage change
Standard Error 5.71
|
3.1 percentage change
Standard Error 5.75
|
-8.9 percentage change
Standard Error 5.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=47 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=49 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=47 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=46 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
|
-68.52 percentage change
Standard Error 2.807
|
-72.45 percentage change
Standard Error 2.761
|
1.24 percentage change
Standard Error 2.801
|
-53.02 percentage change
Standard Error 2.829
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 4
|
-75.25 percentage change
Standard Error 2.401
|
-79.15 percentage change
Standard Error 2.365
|
5.54 percentage change
Standard Error 2.353
|
-62.11 percentage change
Standard Error 2.388
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 8
|
-69.01 percentage change
Standard Error 3.066
|
-73.47 percentage change
Standard Error 3.045
|
2.97 percentage change
Standard Error 3.023
|
-56.09 percentage change
Standard Error 3.074
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 12
|
-63.17 percentage change
Standard Error 3.608
|
-66.62 percentage change
Standard Error 3.542
|
7.38 percentage change
Standard Error 3.599
|
-47.72 percentage change
Standard Error 3.635
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 16
|
-75.61 percentage change
Standard Error 2.379
|
-80.52 percentage change
Standard Error 2.345
|
8.48 percentage change
Standard Error 2.379
|
-63.73 percentage change
Standard Error 2.400
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 20
|
-73.10 percentage change
Standard Error 2.347
|
-76.25 percentage change
Standard Error 2.299
|
4.35 percentage change
Standard Error 2.338
|
-60.50 percentage change
Standard Error 2.360
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 24
|
-68.52 percentage change
Standard Error 2.807
|
-72.45 percentage change
Standard Error 2.761
|
1.24 percentage change
Standard Error 2.801
|
-53.02 percentage change
Standard Error 2.829
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 28
|
-61.43 percentage change
Standard Error 2.921
|
-68.19 percentage change
Standard Error 2.852
|
5.18 percentage change
Standard Error 2.879
|
-49.57 percentage change
Standard Error 2.920
|
—
|
—
|
|
Percent Change From Baseline in ANGPTL3 Over Time
Week 36
|
-53.41 percentage change
Standard Error 3.155
|
-59.85 percentage change
Standard Error 3.066
|
3.73 percentage change
Standard Error 3.110
|
-41.70 percentage change
Standard Error 3.158
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=47 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=49 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=47 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=47 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
|
-18.5 percentage change
Standard Error 2.96
|
-21.5 percentage change
Standard Error 2.89
|
3.1 percentage change
Standard Error 2.91
|
-9.0 percentage change
Standard Error 2.94
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 36 (double-blind treatment period)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=51 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=51 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 4
|
-25.5 percentage change
Standard Error 2.68
|
-24.8 percentage change
Standard Error 2.61
|
-0.3 percentage change
Standard Error 2.59
|
-13.9 percentage change
Standard Error 2.63
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 8
|
-25.0 percentage change
Standard Error 2.74
|
-25.8 percentage change
Standard Error 2.69
|
0.4 percentage change
Standard Error 2.67
|
-14.5 percentage change
Standard Error 2.71
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 12
|
-18.7 percentage change
Standard Error 3.14
|
-18.2 percentage change
Standard Error 3.05
|
2.0 percentage change
Standard Error 3.10
|
-7.0 percentage change
Standard Error 3.11
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 16
|
-28.5 percentage change
Standard Error 3.04
|
-30.2 percentage change
Standard Error 2.96
|
2.1 percentage change
Standard Error 2.99
|
-15.8 percentage change
Standard Error 3.02
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 20
|
-25.1 percentage change
Standard Error 2.94
|
-27.1 percentage change
Standard Error 2.86
|
3.4 percentage change
Standard Error 2.89
|
-11.3 percentage change
Standard Error 2.92
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 24
|
-18.5 percentage change
Standard Error 2.96
|
-21.5 percentage change
Standard Error 2.89
|
3.1 percentage change
Standard Error 2.91
|
-9.0 percentage change
Standard Error 2.94
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 28
|
-14.7 percentage change
Standard Error 2.87
|
-18.6 percentage change
Standard Error 2.77
|
3.0 percentage change
Standard Error 2.78
|
-5.5 percentage change
Standard Error 2.82
|
—
|
—
|
|
Percent Change From Baseline in Fasting HDL-C Over Time
Week 36
|
-13.7 percentage change
Standard Error 2.86
|
-9.4 percentage change
Standard Error 2.75
|
6.4 percentage change
Standard Error 2.78
|
-1.4 percentage change
Standard Error 2.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1: pre-dose, 15 minutes, 1, 3, 6 hours post-dose; Day 2: 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose (double-blind treatment period)Population: Full PK Analysis Set: All participants who received at least 1 dose of active study drug and had at least 1 PK concentration data value. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=18 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=16 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=21 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 1, Pre-Dose
|
0.0000 ng/mL
Standard Deviation 0.00000
|
—
|
0.0000 ng/mL
Standard Deviation 0.00000
|
2.6685 ng/mL
Standard Deviation 12.22871
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 1, 15 Minutes Post-Dose
|
154.7823 ng/mL
Standard Deviation 129.43190
|
—
|
57.6941 ng/mL
Standard Deviation 28.05778
|
63.5267 ng/mL
Standard Deviation 55.85108
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 1, 1 Hour Post-Dose
|
221.5979 ng/mL
Standard Deviation 105.15447
|
—
|
75.3752 ng/mL
Standard Deviation 31.39048
|
130.3387 ng/mL
Standard Deviation 81.73501
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 1, 6 Hours Post-Dose
|
280.0843 ng/mL
Standard Deviation 153.62465
|
—
|
83.9751 ng/mL
Standard Deviation 53.53021
|
152.0097 ng/mL
Standard Deviation 91.30854
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 2, 24 Hours Post-Dose
|
77.9982 ng/mL
Standard Deviation 31.94202
|
—
|
13.3369 ng/mL
Standard Deviation 8.85893
|
33.3047 ng/mL
Standard Deviation 16.31049
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, Pre-Dose
|
1.9366 ng/mL
Standard Deviation 7.74650
|
—
|
0.0000 ng/mL
Standard Deviation 0.00000
|
0.0653 ng/mL
Standard Deviation 0.27695
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, 15 Minutes Post-Dose
|
134.0610 ng/mL
Standard Deviation 138.22698
|
—
|
54.2741 ng/mL
Standard Deviation 43.95835
|
68.3054 ng/mL
Standard Deviation 52.28977
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, 1 Hour Post-Dose
|
247.9728 ng/mL
Standard Deviation 112.83368
|
—
|
76.2131 ng/mL
Standard Deviation 34.49650
|
130.2505 ng/mL
Standard Deviation 52.66507
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, 3 Hours Post-Dose
|
304.2006 ng/mL
Standard Deviation 178.69258
|
—
|
78.2496 ng/mL
Standard Deviation 36.47898
|
152.0302 ng/mL
Standard Deviation 78.31595
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, 6 Hours Post-Dose
|
312.6397 ng/mL
Standard Deviation 174.86753
|
—
|
87.6919 ng/mL
Standard Deviation 37.30155
|
154.3280 ng/mL
Standard Deviation 71.93043
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Week 12, 24 Hours Post-Dose
|
103.1401 ng/mL
Standard Deviation 60.85616
|
—
|
15.3604 ng/mL
Standard Deviation 13.03807
|
36.2506 ng/mL
Standard Deviation 18.33432
|
—
|
—
|
|
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Day 1, 3 Hours Post-Dose
|
259.2799 ng/mL
Standard Deviation 144.46149
|
—
|
77.9834 ng/mL
Standard Deviation 34.90982
|
143.7746 ng/mL
Standard Deviation 79.62215
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of IP up to Week 24Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=52 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=50 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
All TEAEs (Including Serious)
|
29 Participants
|
39 Participants
|
30 Participants
|
37 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
Serious TEAEs
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 36 (double-blind treatment period)Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=51 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=52 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=51 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=50 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
All Treatment-Emergent Adverse Events (TEAEs)
|
34 Participants
|
42 Participants
|
35 Participants
|
40 Participants
|
—
|
—
|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Treatment-related TEAEs
|
8 Participants
|
12 Participants
|
8 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Serious TEAEs
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
TEAEs leading to study drug discontinuation
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Deaths
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Local Injection Site Reactions (LISR)
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug in the OLE up to Month 24 (open-label extension)Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
All Treatment-Emergent Adverse Events (TEAEs)
|
13 Participants
|
30 Participants
|
10 Participants
|
27 Participants
|
10 Participants
|
31 Participants
|
|
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Treatment-related TEAEs
|
4 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Serious TEAEs
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
TEAEs leading to study drug discontinuation
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Deaths
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-52.40 percentage change
Standard Error 6.578
|
-50.56 percentage change
Standard Error 4.288
|
-40.57 percentage change
Standard Error 9.384
|
-47.10 percentage change
Standard Error 3.546
|
-49.06 percentage change
Standard Error 3.275
|
-58.36 percentage change
Standard Error 2.110
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-48.96 percentage change
Standard Error 7.586
|
-51.51 percentage change
Standard Error 2.712
|
-47.14 percentage change
Standard Error 4.687
|
-45.78 percentage change
Standard Error 4.449
|
-48.98 percentage change
Standard Error 6.568
|
-58.66 percentage change
Standard Error 2.135
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-42.05 percentage change
Standard Error 8.623
|
-48.07 percentage change
Standard Error 3.255
|
-40.67 percentage change
Standard Error 5.792
|
-42.51 percentage change
Standard Error 3.294
|
-40.73 percentage change
Standard Error 8.993
|
-56.59 percentage change
Standard Error 2.225
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-48.62 percentage change
Standard Error 7.597
|
-46.81 percentage change
Standard Error 3.828
|
-45.81 percentage change
Standard Error 7.065
|
-48.67 percentage change
Standard Error 4.081
|
-46.34 percentage change
Standard Error 8.818
|
-57.14 percentage change
Standard Error 2.697
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-58.81 percentage change
Standard Error 4.310
|
-56.23 percentage change
Standard Error 2.968
|
-47.40 percentage change
Standard Error 6.442
|
-47.33 percentage change
Standard Error 3.969
|
-44.56 percentage change
Standard Error 4.440
|
-53.57 percentage change
Standard Error 4.055
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-55.29 percentage change
Standard Error 5.170
|
-55.11 percentage change
Standard Error 3.039
|
-48.07 percentage change
Standard Error 6.892
|
-48.48 percentage change
Standard Error 3.041
|
-49.25 percentage change
Standard Error 4.860
|
-51.71 percentage change
Standard Error 4.761
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-58.42 percentage change
Standard Error 3.043
|
-55.23 percentage change
Standard Error 3.101
|
-41.86 percentage change
Standard Error 9.334
|
-45.95 percentage change
Standard Error 3.609
|
-49.30 percentage change
Standard Error 4.388
|
-47.42 percentage change
Standard Error 6.810
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-61.61 percentage change
Standard Error 8.343
|
-56.65 percentage change
Standard Error 3.545
|
-48.23 percentage change
Standard Error 11.315
|
-53.83 percentage change
Standard Error 3.490
|
-51.88 percentage change
Standard Error 3.705
|
-58.96 percentage change
Standard Error 3.563
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
-2.09 percentage change
Standard Error 13.925
|
-39.64 percentage change
Standard Error 3.357
|
-10.02 percentage change
Standard Error 8.711
|
-34.78 percentage change
Standard Error 3.941
|
7.87 percentage change
Standard Error 12.061
|
-51.88 percentage change
Standard Error 2.612
|
|
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-50.45 percentage change
Standard Error 7.323
|
-52.86 percentage change
Standard Error 3.051
|
-43.74 percentage change
Standard Error 5.555
|
-45.32 percentage change
Standard Error 3.994
|
-49.57 percentage change
Standard Error 5.990
|
-62.76 percentage change
Standard Error 2.262
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
-5.02 percentage change
Standard Error 5.171
|
-16.02 percentage change
Standard Error 3.824
|
6.70 percentage change
Standard Error 13.049
|
-19.95 percentage change
Standard Error 3.532
|
-2.53 percentage change
Standard Error 3.750
|
-23.12 percentage change
Standard Error 3.116
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-25.80 percentage change
Standard Error 4.039
|
-25.23 percentage change
Standard Error 3.912
|
-14.79 percentage change
Standard Error 6.493
|
-22.99 percentage change
Standard Error 3.544
|
-28.13 percentage change
Standard Error 3.930
|
-33.41 percentage change
Standard Error 3.158
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-22.32 percentage change
Standard Error 5.340
|
-22.98 percentage change
Standard Error 3.151
|
-14.70 percentage change
Standard Error 5.087
|
-25.54 percentage change
Standard Error 3.730
|
-28.43 percentage change
Standard Error 4.168
|
-30.35 percentage change
Standard Error 3.013
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-19.61 percentage change
Standard Error 4.659
|
-22.97 percentage change
Standard Error 3.462
|
-14.32 percentage change
Standard Error 6.774
|
-20.71 percentage change
Standard Error 3.770
|
-25.19 percentage change
Standard Error 4.215
|
-26.68 percentage change
Standard Error 3.107
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-26.53 percentage change
Standard Error 4.347
|
-24.38 percentage change
Standard Error 3.392
|
-10.42 percentage change
Standard Error 7.330
|
-22.11 percentage change
Standard Error 4.372
|
-30.83 percentage change
Standard Error 4.832
|
-27.84 percentage change
Standard Error 3.414
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-24.42 percentage change
Standard Error 7.159
|
-30.48 percentage change
Standard Error 3.626
|
-13.72 percentage change
Standard Error 9.131
|
-22.82 percentage change
Standard Error 4.267
|
-28.60 percentage change
Standard Error 3.545
|
-30.08 percentage change
Standard Error 2.731
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-25.66 percentage change
Standard Error 3.442
|
-31.53 percentage change
Standard Error 3.040
|
-13.02 percentage change
Standard Error 13.661
|
-24.01 percentage change
Standard Error 4.257
|
-25.86 percentage change
Standard Error 4.405
|
-27.73 percentage change
Standard Error 3.387
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-25.34 percentage change
Standard Error 4.315
|
-33.90 percentage change
Standard Error 3.422
|
-23.39 percentage change
Standard Error 6.010
|
-23.26 percentage change
Standard Error 3.579
|
-29.09 percentage change
Standard Error 4.005
|
-27.88 percentage change
Standard Error 3.495
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-34.23 percentage change
Standard Error 3.783
|
-30.46 percentage change
Standard Error 2.642
|
-13.13 percentage change
Standard Error 14.219
|
-25.07 percentage change
Standard Error 3.492
|
-28.66 percentage change
Standard Error 4.590
|
-25.75 percentage change
Standard Error 3.735
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-37.23 percentage change
Standard Error 3.633
|
-31.95 percentage change
Standard Error 4.492
|
-32.24 percentage change
Standard Error 14.568
|
-27.52 percentage change
Standard Error 5.126
|
-24.24 percentage change
Standard Error 9.558
|
-30.82 percentage change
Standard Error 4.407
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
-10.22 percentage change
Standard Error 4.678
|
-7.48 percentage change
Standard Error 2.924
|
6.57 percentage change
Standard Error 8.959
|
-13.49 percentage change
Standard Error 3.086
|
-3.88 percentage change
Standard Error 3.080
|
-11.77 percentage change
Standard Error 3.309
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-0.30 percentage change
Standard Error 3.518
|
-7.09 percentage change
Standard Error 5.090
|
-5.48 percentage change
Standard Error 13.745
|
-13.01 percentage change
Standard Error 7.131
|
-13.13 percentage change
Standard Error 4.275
|
-8.34 percentage change
Standard Error 3.722
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-1.65 percentage change
Standard Error NA
n=1
|
-4.45 percentage change
Standard Error NA
n=1
|
6.82 percentage change
Standard Error NA
n=1
|
—
|
—
|
-21.63 percentage change
Standard Error NA
n=1
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-3.56 percentage change
Standard Error 6.243
|
-7.93 percentage change
Standard Error 5.968
|
0.31 percentage change
Standard Error 8.213
|
-21.00 percentage change
Standard Error 6.460
|
-11.37 percentage change
Standard Error 16.839
|
-7.58 percentage change
Standard Error 6.338
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-13.84 percentage change
Standard Error 3.803
|
-11.91 percentage change
Standard Error 3.517
|
-1.23 percentage change
Standard Error 7.644
|
-13.89 percentage change
Standard Error 3.645
|
-18.14 percentage change
Standard Error 2.810
|
-14.04 percentage change
Standard Error 3.504
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-13.78 percentage change
Standard Error 6.382
|
-15.14 percentage change
Standard Error 3.520
|
-3.46 percentage change
Standard Error 9.733
|
-12.63 percentage change
Standard Error 3.662
|
-13.87 percentage change
Standard Error 2.996
|
-15.90 percentage change
Standard Error 2.835
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-13.40 percentage change
Standard Error 3.056
|
-16.23 percentage change
Standard Error 2.661
|
-8.08 percentage change
Standard Error 9.722
|
-12.73 percentage change
Standard Error 3.587
|
-11.27 percentage change
Standard Error 4.524
|
-13.05 percentage change
Standard Error 3.530
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-14.12 percentage change
Standard Error 3.655
|
-19.88 percentage change
Standard Error 2.991
|
-14.34 percentage change
Standard Error 5.296
|
-13.83 percentage change
Standard Error 3.624
|
-13.63 percentage change
Standard Error 3.819
|
-13.92 percentage change
Standard Error 3.741
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-21.03 percentage change
Standard Error 3.791
|
-15.03 percentage change
Standard Error 2.910
|
0.08 percentage change
Standard Error 10.835
|
-13.42 percentage change
Standard Error 3.462
|
-15.70 percentage change
Standard Error 4.187
|
-11.85 percentage change
Standard Error 3.789
|
|
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-24.76 percentage change
Standard Error 4.680
|
-16.73 percentage change
Standard Error 4.236
|
-6.57 percentage change
Standard Error 11.292
|
-14.39 percentage change
Standard Error 5.371
|
-10.27 percentage change
Standard Error 8.790
|
-18.04 percentage change
Standard Error 4.441
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
-1.59 percentage change
Standard Error 8.079
|
4.59 percentage change
Standard Error 7.053
|
16.61 percentage change
Standard Error 13.866
|
-7.68 percentage change
Standard Error 4.934
|
4.13 percentage change
Standard Error 5.905
|
-2.82 percentage change
Standard Error 5.633
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-2.47 percentage change
Standard Error 7.839
|
1.94 percentage change
Standard Error 7.628
|
3.79 percentage change
Standard Error 8.934
|
-2.69 percentage change
Standard Error 5.570
|
5.74 percentage change
Standard Error 20.327
|
-1.59 percentage change
Standard Error 6.358
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-10.68 percentage change
Standard Error 5.700
|
-9.92 percentage change
Standard Error 4.137
|
16.09 percentage change
Standard Error 11.331
|
-2.03 percentage change
Standard Error 6.503
|
3.32 percentage change
Standard Error 20.431
|
-2.80 percentage change
Standard Error 6.230
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-4.64 percentage change
Standard Error 9.376
|
-8.25 percentage change
Standard Error 7.573
|
6.95 percentage change
Standard Error 14.056
|
-2.77 percentage change
Standard Error 6.090
|
4.05 percentage change
Standard Error 18.896
|
-6.97 percentage change
Standard Error 4.466
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-7.43 percentage change
Standard Error 5.762
|
-0.07 percentage change
Standard Error 7.654
|
6.61 percentage change
Standard Error 8.960
|
-4.90 percentage change
Standard Error 5.203
|
3.74 percentage change
Standard Error 16.591
|
-10.01 percentage change
Standard Error 4.929
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-3.40 percentage change
Standard Error 7.119
|
7.38 percentage change
Standard Error 12.473
|
5.75 percentage change
Standard Error 6.546
|
-10.81 percentage change
Standard Error 5.105
|
3.50 percentage change
Standard Error 20.049
|
-10.08 percentage change
Standard Error 4.989
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-6.14 percentage change
Standard Error 6.380
|
-5.41 percentage change
Standard Error 11.638
|
8.54 percentage change
Standard Error 17.305
|
-7.84 percentage change
Standard Error 6.363
|
5.82 percentage change
Standard Error 18.362
|
-7.85 percentage change
Standard Error 5.264
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-4.52 percentage change
Standard Error 7.677
|
-13.20 percentage change
Standard Error 7.882
|
-9.73 percentage change
Standard Error 8.195
|
-5.88 percentage change
Standard Error 5.801
|
6.86 percentage change
Standard Error 21.962
|
-8.43 percentage change
Standard Error 5.346
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-12.81 percentage change
Standard Error 7.465
|
-4.47 percentage change
Standard Error 8.744
|
9.29 percentage change
Standard Error 18.925
|
-6.14 percentage change
Standard Error 5.553
|
-15.64 percentage change
Standard Error 7.008
|
-2.16 percentage change
Standard Error 5.032
|
|
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-12.81 percentage change
Standard Error 9.496
|
-13.83 percentage change
Standard Error 5.902
|
-7.17 percentage change
Standard Error 22.117
|
-10.57 percentage change
Standard Error 6.996
|
-9.58 percentage change
Standard Error 14.506
|
-6.18 percentage change
Standard Error 6.423
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
4.47 percentage change
Standard Error 7.595
|
-56.81 percentage change
Standard Error 3.166
|
3.41 percentage change
Standard Error 5.372
|
-41.57 percentage change
Standard Error 4.417
|
0.79 percentage change
Standard Error 4.664
|
-59.24 percentage change
Standard Error 3.551
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-77.02 percentage change
Standard Error 2.699
|
-76.03 percentage change
Standard Error 1.982
|
-59.55 percentage change
Standard Error 3.490
|
-65.83 percentage change
Standard Error 2.836
|
-74.62 percentage change
Standard Error 3.753
|
-77.96 percentage change
Standard Error 2.273
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-67.75 percentage change
Standard Error 4.771
|
-71.21 percentage change
Standard Error 2.367
|
-53.85 percentage change
Standard Error 3.393
|
-60.01 percentage change
Standard Error 3.812
|
-70.19 percentage change
Standard Error 3.928
|
-74.59 percentage change
Standard Error 2.775
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-61.65 percentage change
Standard Error 4.510
|
-65.54 percentage change
Standard Error 3.020
|
-43.36 percentage change
Standard Error 5.072
|
-48.56 percentage change
Standard Error 6.842
|
-64.79 percentage change
Standard Error 5.478
|
-68.91 percentage change
Standard Error 3.310
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-67.23 percentage change
Standard Error 4.070
|
-68.85 percentage change
Standard Error 2.867
|
-49.22 percentage change
Standard Error 5.280
|
-54.18 percentage change
Standard Error 4.076
|
-69.38 percentage change
Standard Error 3.736
|
-67.04 percentage change
Standard Error 3.743
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-71.03 percentage change
Standard Error 4.370
|
-69.32 percentage change
Standard Error 3.691
|
-55.48 percentage change
Standard Error 5.056
|
-55.20 percentage change
Standard Error 4.666
|
-63.23 percentage change
Standard Error 5.801
|
-62.00 percentage change
Standard Error 4.122
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-65.80 percentage change
Standard Error 4.669
|
-65.28 percentage change
Standard Error 6.196
|
-53.01 percentage change
Standard Error 3.998
|
-52.97 percentage change
Standard Error 4.560
|
-64.57 percentage change
Standard Error 3.909
|
-55.73 percentage change
Standard Error 5.734
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-65.71 percentage change
Standard Error 4.877
|
-65.97 percentage change
Standard Error 3.280
|
-36.82 percentage change
Standard Error 9.076
|
-39.57 percentage change
Standard Error 5.638
|
-61.38 percentage change
Standard Error 4.943
|
-55.31 percentage change
Standard Error 4.725
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-63.26 percentage change
Standard Error 4.176
|
-64.68 percentage change
Standard Error 3.414
|
-40.12 percentage change
Standard Error 5.814
|
-43.45 percentage change
Standard Error 5.176
|
-58.10 percentage change
Standard Error 4.837
|
-55.43 percentage change
Standard Error 4.784
|
|
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-48.46 percentage change
Standard Error 14.321
|
-62.95 percentage change
Standard Error 4.439
|
-44.08 percentage change
Standard Error 10.028
|
-50.18 percentage change
Standard Error 6.570
|
-61.52 percentage change
Standard Error 3.012
|
-63.89 percentage change
Standard Error 4.009
|
SECONDARY outcome
Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Outcome measures
| Measure |
ARO-ANG3 100 mg
n=14 Participants
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 200 mg
n=39 Participants
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo
n=13 Participants
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg
n=36 Participants
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 Participants
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
ARO-ANG3 200 mg/ARO-ANG3 200 mg
n=41 Participants
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Baseline/OLE Day 1
|
7.70 percentage change
Standard Error 5.318
|
-12.88 percentage change
Standard Error 3.147
|
13.70 percentage change
Standard Error 6.036
|
1.67 percentage change
Standard Error 3.360
|
4.80 percentage change
Standard Error 4.562
|
-11.26 percentage change
Standard Error 3.771
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 1
|
-26.62 percentage change
Standard Error 4.804
|
-28.81 percentage change
Standard Error 3.214
|
-10.68 percentage change
Standard Error 8.416
|
-12.31 percentage change
Standard Error 3.791
|
-14.33 percentage change
Standard Error 8.371
|
-28.27 percentage change
Standard Error 3.705
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 2
|
-19.64 percentage change
Standard Error 4.846
|
-24.78 percentage change
Standard Error 3.397
|
-9.46 percentage change
Standard Error 6.308
|
-10.98 percentage change
Standard Error 3.588
|
-13.48 percentage change
Standard Error 7.252
|
-28.24 percentage change
Standard Error 3.362
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 3
|
-15.50 percentage change
Standard Error 4.847
|
-22.29 percentage change
Standard Error 3.771
|
-8.80 percentage change
Standard Error 5.376
|
-9.96 percentage change
Standard Error 3.318
|
-12.81 percentage change
Standard Error 5.209
|
-19.78 percentage change
Standard Error 3.504
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 6
|
-21.38 percentage change
Standard Error 6.028
|
-26.54 percentage change
Standard Error 3.486
|
-8.26 percentage change
Standard Error 6.279
|
-3.95 percentage change
Standard Error 4.247
|
-13.75 percentage change
Standard Error 6.207
|
-20.43 percentage change
Standard Error 4.082
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 12
|
-22.23 percentage change
Standard Error 5.893
|
-26.51 percentage change
Standard Error 3.816
|
-13.83 percentage change
Standard Error 7.363
|
-16.58 percentage change
Standard Error 3.672
|
-5.47 percentage change
Standard Error 5.504
|
-18.32 percentage change
Standard Error 4.314
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 15
|
-19.76 percentage change
Standard Error 5.356
|
-29.44 percentage change
Standard Error 3.110
|
-9.01 percentage change
Standard Error 6.448
|
-12.02 percentage change
Standard Error 5.116
|
-14.07 percentage change
Standard Error 5.004
|
-15.04 percentage change
Standard Error 4.116
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 18
|
-21.60 percentage change
Standard Error 5.268
|
-28.55 percentage change
Standard Error 3.462
|
-10.53 percentage change
Standard Error 6.499
|
-4.80 percentage change
Standard Error 5.980
|
-11.86 percentage change
Standard Error 4.787
|
-16.39 percentage change
Standard Error 4.648
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 21
|
-22.77 percentage change
Standard Error 4.713
|
-26.12 percentage change
Standard Error 3.535
|
-3.87 percentage change
Standard Error 6.823
|
-12.48 percentage change
Standard Error 3.816
|
-16.68 percentage change
Standard Error 2.024
|
-17.82 percentage change
Standard Error 3.788
|
|
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Percent Change from Baseline to OLE Month 24
|
-20.28 percentage change
Standard Error 15.397
|
-27.31 percentage change
Standard Error 4.225
|
-8.97 percentage change
Standard Error 10.168
|
-11.66 percentage change
Standard Error 5.293
|
-16.01 percentage change
Standard Error 3.759
|
-24.10 percentage change
Standard Error 5.009
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 41 other events
Deaths: 1 deaths
ARO-ANG3 50 mg
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
ARO-ANG3 100 mg
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
ARO-ANG3 200 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo/ARO-ANG3 50 mg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
ARO-ANG3 50 mg/ARO-ANG3 50 mg
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo/ARO-ANG3 100 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
ARO-ANG3 100 mg/ARO-ANG3 100 mg
Serious events: 5 serious events
Other events: 34 other events
Deaths: 1 deaths
Placebo/ARO-ANG3 200 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
ARO-ANG3 200mg/ARO-ANG3 200 mg
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 50 mg
n=50 participants at risk
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 100 mg
n=51 participants at risk
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 200 mg
n=52 participants at risk
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
Placebo/ARO-ANG3 50 mg
n=13 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg/ARO-ANG3 50 mg
n=36 participants at risk
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 100 mg
n=14 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg/ARO-ANG3 100 mg
n=39 participants at risk
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 participants at risk
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
ARO-ANG3 200mg/ARO-ANG3 200 mg
n=41 participants at risk
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Angina unstable
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Death
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Influenza
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 50 mg
n=50 participants at risk
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 100 mg
n=51 participants at risk
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
ARO-ANG3 200 mg
n=52 participants at risk
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
|
Placebo/ARO-ANG3 50 mg
n=13 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
ARO-ANG3 50 mg/ARO-ANG3 50 mg
n=36 participants at risk
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 100 mg
n=14 participants at risk
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
ARO-ANG3 100 mg/ARO-ANG3 100 mg
n=39 participants at risk
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
|
Placebo/ARO-ANG3 200 mg
n=13 participants at risk
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
ARO-ANG3 200mg/ARO-ANG3 200 mg
n=41 participants at risk
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Splenic cyst
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Aortic valve sclerosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Hypertensive heart disease
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Mitral valve incompetence
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Myocardial ischaemia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Suprventricular tachycardia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Eye disorders
Cataract
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Eye disorders
Chalazion
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Defaecation urgency
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Dental caries
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.3%
4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.8%
4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Hiatus hernia
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Tooth impacted
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Administration site reaction
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Asthenia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Fatigue
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Influenza like illness
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Injection site bruising
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Injection site erythema
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.5%
6/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.6%
6/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Injection site induration
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Injection site pain
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.0%
5/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
13.7%
7/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.1%
4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
6/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Injection site pruritus
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Malaise
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
General disorders
Peripheral swelling
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Hepatobiliary disorders
Hepatic cyst
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Immune system disorders
Drug hypersensitivity
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Acute sinusitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.3%
4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19
|
27.5%
14/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
32.0%
16/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
31.4%
16/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
34.6%
18/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
23.1%
3/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
38.9%
14/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
35.7%
5/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
33.3%
13/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
30.8%
4/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
36.6%
15/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Ear infection
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Fungal skin infection
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Gastroenteritis
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.4%
3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Helicobacter gastritis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Infective exacerbation of asthma
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Labyrinthitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Postoperative wound infection
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Pyuria
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Respiratory tract infection
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Sinusitis
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.8%
4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Subcutaneous abscess
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.7%
7/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
16.0%
8/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
17.6%
9/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.2%
11/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
16.7%
6/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.4%
3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
23.1%
9/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
22.0%
9/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
12.0%
6/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.8%
6/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
23.1%
12/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.1%
4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.3%
4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
19.5%
8/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Viral pharyngitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Infections and infestations
Wound infection
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ear canal injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Amylase increased
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Bacterial test positive
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Blood glucose increased
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Blood potassium decreased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
C-reactive protein increased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Cardiac murmur
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Glycosylated haemoglobin increased
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.0%
4/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.1%
4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
High density lipoprotein decreased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Lipase increased
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Low density lipoprotein increased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Troponin increased
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
Urine analysis abnormal
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Investigations
White blood cells urine positive
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Gout
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
9.8%
5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.0%
4/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
13.5%
7/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.4%
3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
17.1%
7/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.4%
3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.3%
4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.8%
4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
10.0%
5/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
8/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
13.9%
5/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
19.5%
8/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Amnesia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.8%
5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.3%
3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.6%
5/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
12.2%
5/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Diabetic neuropathy
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.8%
4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
11.8%
6/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
12.0%
6/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
17.3%
9/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
11.1%
4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
21.4%
3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.6%
6/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Hypokinesia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Loss of consciousness
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Psychiatric disorders
Adjustment disorder
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Psychiatric disorders
Insomnia
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
14.3%
2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Renal cyst
|
5.9%
3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
15.4%
2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.8%
4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.8%
2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
6.0%
3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
8.3%
3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Vascular disorders
Hot flush
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.8%
1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
1.9%
1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.4%
1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.8%
3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.9%
2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.1%
1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
2.6%
1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
4.0%
2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
3.9%
2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.6%
5/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.6%
2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
5.1%
2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
9.8%
4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
|
Vascular disorders
Superficial vein thrombosis
|
2.0%
1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
7.7%
1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
0.00%
0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
|
Additional Information
Patrick O'Brien, Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER