Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a) (NCT NCT02160899)
NCT ID: NCT02160899
Last Updated: 2019-12-20
Results Overview
Data are reported for evaluable participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Day 85/Day 99
Results posted on
2019-12-20
Participant Flow
A total of 51 participants were enrolled in Cohort A and 13 participants were enrolled in Cohort B.
A total of 86 participants were screened for the study and 64 participants were randomized into Cohort A and Cohort B and received study treatment. Two participants in Cohort B did not complete the study treatment but completed the post-treatment follow-up.
Participant milestones
| Measure |
Cohort A: Placebo
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
4
|
21
|
3
|
2
|
8
|
|
Overall Study
COMPLETED
|
26
|
3
|
21
|
2
|
0
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Placebo
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event or Serious Adverse Event
|
0
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)
Baseline characteristics by cohort
| Measure |
Cohort A: Placebo
n=26 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
n=4 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
n=21 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
n=3 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
n=2 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
n=8 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10 • n=5 Participants
|
50 years
STANDARD_DEVIATION 9 • n=7 Participants
|
56 years
STANDARD_DEVIATION 6 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8 • n=4 Participants
|
45 years
STANDARD_DEVIATION 11 • n=21 Participants
|
61 years
STANDARD_DEVIATION 8 • n=8 Participants
|
55 years
STANDARD_DEVIATION 8.90 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
62 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 85/Day 99Population: The Per-Protocol Set included the subset of the Full Analysis Set who received at least 9 doses of Study Drug within the 12-week treatment period and who had no significant protocol deviations that would have been expected to affect efficacy assessments. Day 85/Day 99 result is defined as the result at Day 85 or Day 99.
Data are reported for evaluable participants.
Outcome measures
| Measure |
Cohort A: Placebo
n=26 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
n=3 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
n=21 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
n=2 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
n=8 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99
|
-3.7 percent change
Standard Deviation 13.7
|
-44.5 percent change
Standard Deviation 13.1
|
-70.0 percent change
Standard Deviation 19.6
|
-5.6 percent change
Standard Deviation 3.9
|
—
|
-71.6 percent change
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: Up to approximately 32 weeksPopulation: The Safety Set included all randomized participants who received at least one dose of study drug.
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
Outcome measures
| Measure |
Cohort A: Placebo
n=26 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
n=4 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
n=21 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
n=3 Participants
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
n=2 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
n=8 Participants
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
23 Participants
|
4 Participants
|
21 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
Adverse Events
Cohort A: Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort A: ISIS-APO(a)Rx < 2000 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A: ISIS-APO(a)Rx >= 2000 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort B: Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: ISIS-APO(a)Rx < 2000 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: ISIS-APO(a)Rx >= 2000 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Placebo
n=26 participants at risk
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
n=4 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
n=21 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
n=3 participants at risk
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
n=2 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
n=8 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort A: Placebo
n=26 participants at risk
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort A: ISIS-APO(a)Rx < 2000 mg
n=4 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort A: ISIS-APO(a)Rx >= 2000 mg
n=21 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: Placebo
n=3 participants at risk
Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
Cohort B: ISIS-APO(a)Rx < 2000 mg
n=2 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
Cohort B: ISIS-APO(a)Rx >= 2000 mg
n=8 participants at risk
Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
75.0%
3/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
76.2%
16/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
100.0%
2/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
75.0%
6/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
57.1%
12/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
100.0%
2/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
75.0%
3/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
38.1%
8/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
4/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
47.6%
10/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site warmth
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
11.5%
3/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
2/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
2/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
38.1%
8/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
7/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site hyperaesthesia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site discolouration
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
23.8%
5/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
2/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
11.5%
3/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
19.0%
4/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site haematoma
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site urticaria
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Hyperthermia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site oedema
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pallor
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
11.5%
3/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
34.6%
9/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
38.1%
8/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteriuria
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
23.1%
6/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
47.6%
10/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
19.0%
4/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
19.0%
4/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
4/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
2/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
6/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
2/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
2/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
9.5%
2/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
3/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
14.3%
3/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
3.8%
1/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
4.8%
1/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Pallor
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/26 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/21 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
33.3%
1/3 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 32 weeks
The Safety Set included all randomized participants who received at least one dose of study drug.
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Phone: 800-679-4747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place