Trial Outcomes & Findings for Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator (NCT NCT02104583)
NCT ID: NCT02104583
Last Updated: 2019-04-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
313 participants
Primary outcome timeframe
Randomization up to 24 weeks
Results posted on
2019-04-09
Participant Flow
Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 12 September 2014. The last study visit occurred on 14 October 2016.
389 participants were screened.
Participant milestones
| Measure |
Cohort 1 Eleclazine 3 mg
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
Participants were randomized to receive single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
70
|
74
|
75
|
|
Overall Study
COMPLETED
|
30
|
35
|
54
|
57
|
63
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
16
|
17
|
12
|
Reasons for withdrawal
| Measure |
Cohort 1 Eleclazine 3 mg
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
Participants were randomized to receive single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
|---|---|---|---|---|---|
|
Overall Study
New ICD or CRT-D implanted
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
2
|
1
|
3
|
3
|
5
|
|
Overall Study
Subject required cardiac ablation
|
6
|
4
|
4
|
5
|
4
|
|
Overall Study
Subject required prohibited medication
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
3
|
2
|
0
|
2
|
1
|
|
Overall Study
Investigator's Discretion
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
3
|
6
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized but Never Treated
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets On Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months
|
Cohort 2 Eleclazine 3 mg
n=70 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=74 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10.4 • n=48 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
64 years
STANDARD_DEVIATION 9.6 • n=46 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
65 years
STANDARD_DEVIATION 10.8 • n=70 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
65 years
STANDARD_DEVIATION 8.3 • n=73 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
64 years
STANDARD_DEVIATION 9.4 • n=75 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
65 years
STANDARD_DEVIATION 9.6 • n=312 Participants • Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Sex: Female, Male
Female
|
4 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
5 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
8 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
7 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
8 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
32 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Sex: Female, Male
Male
|
44 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
41 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
62 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
66 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
67 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
280 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
2 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
5 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · White
|
47 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
45 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
70 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
70 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
71 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
303 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Not permitted
|
0 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
2 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
3 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
2 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
47 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
45 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
70 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
71 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
73 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
306 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=48 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=46 Participants • Participants in the Safety Analysis Set were analyzed.
|
0 Participants
n=70 Participants • Participants in the Safety Analysis Set were analyzed.
|
1 Participants
n=73 Participants • Participants in the Safety Analysis Set were analyzed.
|
2 Participants
n=75 Participants • Participants in the Safety Analysis Set were analyzed.
|
4 Participants
n=312 Participants • Participants in the Safety Analysis Set were analyzed.
|
|
Region of Enrollment
United States
|
25 Participants
n=48 Participants
|
24 Participants
n=46 Participants
|
20 Participants
n=70 Participants
|
24 Participants
n=74 Participants
|
24 Participants
n=75 Participants
|
117 Participants
n=313 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=48 Participants
|
7 Participants
n=46 Participants
|
18 Participants
n=70 Participants
|
11 Participants
n=74 Participants
|
15 Participants
n=75 Participants
|
57 Participants
n=313 Participants
|
|
Region of Enrollment
Israel
|
9 Participants
n=48 Participants
|
8 Participants
n=46 Participants
|
6 Participants
n=70 Participants
|
9 Participants
n=74 Participants
|
6 Participants
n=75 Participants
|
38 Participants
n=313 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=48 Participants
|
4 Participants
n=46 Participants
|
9 Participants
n=70 Participants
|
10 Participants
n=74 Participants
|
9 Participants
n=75 Participants
|
35 Participants
n=313 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=48 Participants
|
1 Participants
n=46 Participants
|
7 Participants
n=70 Participants
|
7 Participants
n=74 Participants
|
9 Participants
n=75 Participants
|
24 Participants
n=313 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
3 Participants
n=70 Participants
|
3 Participants
n=74 Participants
|
6 Participants
n=75 Participants
|
12 Participants
n=313 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
4 Participants
n=70 Participants
|
5 Participants
n=74 Participants
|
3 Participants
n=75 Participants
|
12 Participants
n=313 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
3 Participants
n=70 Participants
|
4 Participants
n=74 Participants
|
1 Participants
n=75 Participants
|
10 Participants
n=313 Participants
|
|
Region of Enrollment
Czechia
|
3 Participants
n=48 Participants
|
2 Participants
n=46 Participants
|
0 Participants
n=70 Participants
|
1 Participants
n=74 Participants
|
2 Participants
n=75 Participants
|
8 Participants
n=313 Participants
|
PRIMARY outcome
Timeframe: Randomization up to 24 weeksPopulation: Participants in the Full Analysis Set-ICD \[all participants who were randomized into the study and received at least 1 dose of study medication, restricted to participants who had at least 1 postbaseline ICD/cardiac resynchronization therapy-defibrillator (CRT-D) interrogation\] with available data were analyzed.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=69 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
n=117 Participants
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
n=121 Participants
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24
|
3.3 events
Standard Deviation 6.99
|
1.9 events
Standard Deviation 3.79
|
2.6 events
Standard Deviation 6.8
|
1.1 events
Standard Deviation 2.09
|
1.5 events
Standard Deviation 3.92
|
2.8 events
Standard Deviation 6.86
|
1.7 events
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Randomization up to 22 monthsPopulation: Participants in the Full Analysis Set-ICD with available data were analyzed.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=69 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
n=117 Participants
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
n=121 Participants
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study
|
5.0 events
Standard Deviation 7.92
|
7.2 events
Standard Deviation 20.89
|
3.8 events
Standard Deviation 8.82
|
1.2 events
Standard Deviation 2.11
|
2.0 events
Standard Deviation 5.55
|
4.3 events
Standard Deviation 8.45
|
4.0 events
Standard Deviation 13.75
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set (all participants who were randomized into the study and received at least 1 dose of study medication) with available data were analyzed.
PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=41 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=40 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=58 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=56 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=63 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring
|
4282 episodes/48 hours
Standard Deviation 17651.5
|
-2347 episodes/48 hours
Standard Deviation 8498.8
|
-594 episodes/48 hours
Standard Deviation 13323.0
|
-39 episodes/48 hours
Standard Deviation 13575.0
|
1541 episodes/48 hours
Standard Deviation 11117.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=41 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=40 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=58 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=56 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=63 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring
|
44 episodes/48 hours
Standard Deviation 171.6
|
-14 episodes/48 hours
Standard Deviation 52.2
|
-67 episodes/48 hours
Standard Deviation 400.4
|
46 episodes/48 hours
Standard Deviation 388.4
|
2 episodes/48 hours
Standard Deviation 15.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization up to Week 24; Randomization up to end of study (up to 22 months)Population: Participants in the Full Analysis Set-ICD with available data were analyzed.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=69 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study
Total Number of Events Through Week 24
|
3.56 events
Standard Deviation 7.554
|
2.07 events
Standard Deviation 3.974
|
2.74 events
Standard Deviation 6.825
|
1.44 events
Standard Deviation 2.779
|
1.61 events
Standard Deviation 3.952
|
—
|
—
|
|
Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study
Total Number of Events Through End of Study
|
5.98 events
Standard Deviation 8.907
|
7.83 events
Standard Deviation 20.949
|
4.07 events
Standard Deviation 9.088
|
1.56 events
Standard Deviation 2.794
|
2.17 events
Standard Deviation 5.574
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization up to Week 24; Randomization up to end of study (up to 22 months)Population: Participants in the Full Analysis Set-ICD with available data were analyzed.
An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=69 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study
Total Number of Events Through Week 24
|
0.15 events
Standard Deviation 0.545
|
0.15 events
Standard Deviation 0.631
|
0.23 events
Standard Deviation 0.843
|
0.03 events
Standard Deviation 0.164
|
0.09 events
Standard Deviation 0.408
|
—
|
—
|
|
Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study
Total Number of Events Through End of Study
|
0.21 events
Standard Deviation 0.582
|
0.63 events
Standard Deviation 2.037
|
0.35 events
Standard Deviation 1.041
|
0.03 events
Standard Deviation 0.164
|
0.12 events
Standard Deviation 0.614
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization up to Week 24; Randomization up to end of study (up to 22 months)Population: Participants in the Full Analysis Set-ICD with available data were analyzed.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=69 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study
Total Number of Events Through Week 24
|
0.17 events
Standard Deviation 0.753
|
0.15 events
Standard Deviation 0.515
|
0.14 events
Standard Deviation 0.772
|
0.12 events
Standard Deviation 6.22
|
0.39 events
Standard Deviation 2.283
|
—
|
—
|
|
Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study
Total Number of Events Through End of Study
|
0.31 events
Standard Deviation 1.613
|
0.41 events
Standard Deviation 2.072
|
0.16 events
Standard Deviation 0.779
|
0.14 events
Standard Deviation 0.631
|
0.43 events
Standard Deviation 2.395
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12; Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=43 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=45 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=57 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=60 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=66 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
Change at Week 24
|
1 percentage of blood
Standard Deviation 12.3
|
2 percentage of blood
Standard Deviation 8.2
|
3 percentage of blood
Standard Deviation 10.0
|
1 percentage of blood
Standard Deviation 10.7
|
0 percentage of blood
Standard Deviation 8.3
|
—
|
—
|
|
Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
Baseline
|
35 percentage of blood
Standard Deviation 12.8
|
38 percentage of blood
Standard Deviation 12.4
|
38 percentage of blood
Standard Deviation 12.1
|
38 percentage of blood
Standard Deviation 13.3
|
40 percentage of blood
Standard Deviation 13.5
|
—
|
—
|
|
Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
Change at Week 12
|
3 percentage of blood
Standard Deviation 8.1
|
3 percentage of blood
Standard Deviation 6.2
|
3 percentage of blood
Standard Deviation 9.1
|
3 percentage of blood
Standard Deviation 8.2
|
1 percentage of blood
Standard Deviation 8.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 22 monthsPopulation: Participants in the Full Analysis Set with available data were analyzed.
CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=70 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=73 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=75 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=118 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=121 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death
|
252.0 days
Interval 147.0 to
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
243.0 days
Interval 147.0 to 281.0
|
265.0 days
Interval 130.0 to 496.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 22 monthsPopulation: Participants in the Full Analysis Set with available data were analyzed.
CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.
Outcome measures
| Measure |
Cohort 1 Eleclazine 3 mg
n=70 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=73 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=75 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=118 Participants
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=121 Participants
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
Cohorts 1 and 2, Eleclazine 3 mg
All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
|
Cohorts 1 and 2, Placebo
All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
|
|---|---|---|---|---|---|---|---|
|
Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
NA days
Data was not estimable as more than 50% of participants were censored.
|
—
|
—
|
Adverse Events
Cohort 1 Eleclazine 3 mg
Serious events: 27 serious events
Other events: 32 other events
Deaths: 0 deaths
Cohort 1 Placebo
Serious events: 25 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 2 Eleclazine 3 mg
Serious events: 28 serious events
Other events: 42 other events
Deaths: 0 deaths
Cohort 2 Eleclazine 6 mg
Serious events: 26 serious events
Other events: 34 other events
Deaths: 0 deaths
Cohort 2 Placebo
Serious events: 26 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 participants at risk
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=70 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 participants at risk
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Anginal equivalent
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.3%
4/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cor pulmonale
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.7%
5/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
22.9%
11/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
21.7%
10/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
10.0%
7/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
13.7%
10/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
10.7%
8/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Coeliac artery compression syndrome
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Phantom shocks
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis pseudomonal
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
3/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Parosmia
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
4.2%
2/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Product Issues
Device dislocation
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Product Issues
Device inappropriate shock delivery
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Product Issues
Device malfunction
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
4.2%
2/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cohort 1 Eleclazine 3 mg
n=48 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
|
Cohort 1 Placebo
n=46 participants at risk
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
|
Cohort 2 Eleclazine 3 mg
n=70 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Eleclazine 6 mg
n=73 participants at risk
Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
|
Cohort 2 Placebo
n=75 participants at risk
Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
3/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
16.7%
8/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
11.4%
8/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
9.6%
7/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
12.0%
9/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
10.4%
5/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
15.2%
7/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.6%
6/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.7%
5/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
3/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.7%
4/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.8%
5/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.3%
1/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.7%
4/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.6%
6/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
11.0%
8/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
4/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
3/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
4.2%
2/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.7%
4/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
10.9%
5/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
5/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.7%
4/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
10.0%
7/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
6.7%
5/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
6.2%
3/48 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
2.7%
2/75 • First dose of study drug to last dose date (maximum: approximately 96.1 weeks) plus 30 days
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER