Trial Outcomes & Findings for APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy) (NCT NCT03997383)
NCT ID: NCT03997383
Last Updated: 2026-01-12
Results Overview
Distance in meters walked in 6 minutes, longer distances indicate greater functional capacity. Missing 6MWT values due to non-COVID-19 death or inability to walk due to ATTR disease progression were imputed using the worst 10th percentile change observed in the DB period. Missing 6-MWT values due to other reasons are multiply imputed to create 100 complete datasets. The change from baseline is averaged across the 100 complete datasets.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
360 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2026-01-12
Participant Flow
Participant milestones
| Measure |
Placebo (DB)/Patisiran (OLE)
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Double-blind Treatment Period
STARTED
|
179
|
181
|
|
Double-blind Treatment Period
Treated
|
178
|
181
|
|
Double-blind Treatment Period
COMPLETED
|
166
|
168
|
|
Double-blind Treatment Period
NOT COMPLETED
|
13
|
13
|
|
Open-label Extension Period
STARTED
|
166
|
168
|
|
Open-label Extension Period
COMPLETED
|
0
|
0
|
|
Open-label Extension Period
NOT COMPLETED
|
166
|
168
|
Reasons for withdrawal
| Measure |
Placebo (DB)/Patisiran (OLE)
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Double-blind Treatment Period
Adverse Event
|
4
|
3
|
|
Double-blind Treatment Period
Death
|
4
|
4
|
|
Double-blind Treatment Period
Physician Decision
|
2
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
3
|
6
|
|
Open-label Extension Period
Ongoing
|
148
|
151
|
|
Open-label Extension Period
Adverse Event
|
4
|
1
|
|
Open-label Extension Period
Death
|
8
|
9
|
|
Open-label Extension Period
Physician Decision
|
1
|
1
|
|
Open-label Extension Period
Subject Stopped Participation in the Study
|
3
|
6
|
|
Open-label Extension Period
Reason Not Specified
|
2
|
0
|
Baseline Characteristics
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Baseline characteristics by cohort
| Measure |
Placebo (DB)/Patisiran (OLE)
n=178 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
n=181 Participants
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 7.8 • n=210 Participants
|
75.3 years
STANDARD_DEVIATION 6.5 • n=19 Participants
|
74.8 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=210 Participants
|
20 Participants
n=19 Participants
|
38 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=210 Participants
|
161 Participants
n=19 Participants
|
321 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 participants
n=210 Participants
|
23 participants
n=19 Participants
|
38 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 participants
n=210 Participants
|
16 participants
n=19 Participants
|
31 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
140 participants
n=210 Participants
|
138 participants
n=19 Participants
|
278 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=210 Participants
|
3 participants
n=19 Participants
|
7 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
4 participants
n=210 Participants
|
5 participants
n=19 Participants
|
9 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 participants
n=210 Participants
|
21 participants
n=19 Participants
|
41 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
150 participants
n=210 Participants
|
153 participants
n=19 Participants
|
303 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 participants
n=210 Participants
|
2 participants
n=19 Participants
|
6 participants
n=8 Participants
|
|
6 Minute Walk Test (6MWT)
|
367.7 meters
n=210 Participants
|
356.8 meters
n=19 Participants
|
362.0 meters
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: All randomized participants who received any amount of study drug. Participants were analyzed according to the treatment to which they were randomized.
Distance in meters walked in 6 minutes, longer distances indicate greater functional capacity. Missing 6MWT values due to non-COVID-19 death or inability to walk due to ATTR disease progression were imputed using the worst 10th percentile change observed in the DB period. Missing 6-MWT values due to other reasons are multiply imputed to create 100 complete datasets. The change from baseline is averaged across the 100 complete datasets.
Outcome measures
| Measure |
Placebo (DB)/Patisiran (OLE)
n=178 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
n=181 Participants
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Change From Baseline at Month 12 in Six-Minute Walk Test (6-MWT)
|
-21.345 meters
Interval -68.268 to 12.75
|
-8.150 meters
Interval -54.651 to 29.51
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: All randomized participants who received any amount of study drug. Participants were analyzed according to the treatment to which they were randomized. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis at the specified timepoint.
The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \[OS\]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Placebo (DB)/Patisiran (OLE)
n=164 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
n=170 Participants
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Change From Baseline at Month 12 in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Score
|
-3.396 score on a scale
Standard Error 1.356
|
0.478 score on a scale
Standard Error 1.363
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Participants from the Full Analysis Set (all randomized participants who received any amount of study drug (either placebo or patisiran), grouped based on their use of tafamidis at Baseline as pre-specified in the study protocol.
The composite endpoint was analyzed using the stratified win ratio method, stratified by baseline tafamidis use. This method combines all-cause mortality, frequency of CV events (CV hospitalizations and HF visits) and change from baseline in 6-MWT in a hierarchical fashion. This method makes within-stratum pairwise comparisons for all patisiran-placebo participant pairs in a sequential manner (first mortality, then CV events, then 6-MWT), with later steps evaluated only in the case of a tie on the prior step. Within each stratum, the win ratio is the total number of 'winners' divided by the total number of 'losers' in the active group. A win ratio \>1 represents a favorable outcome for patisiran.
Outcome measures
| Measure |
Placebo (DB)/Patisiran (OLE)
n=91 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
n=268 Participants
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Composite Endpoint of All-Cause Mortality, Frequency of Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) and Change From Baseline in 6-MWT Analyzed by Win Ratio
|
1.22 win ratio
Interval 0.76 to 1.95
|
1.28 win ratio
Interval 0.97 to 1.7
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Participants from the Full Analysis Set \[all randomized participants who received any amount of study drug (placebo or patisiran)\] and were not receiving tafamidis at Baseline were included in the data analysis for the outcome measure as pre-specified in the study protocol.
The hazard rate of all-cause mortality and all-cause hospitalizations and urgent HF visits will be compared between treatment groups using an Andersen-Gill model. A hazard ratio \<1 represents a favorable outcome for patisiran.
Outcome measures
| Measure |
Placebo (DB)/Patisiran (OLE)
n=268 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Composite Endpoint of All-Cause Mortality and Frequency of All-Cause Hospitalizations and Urgent HF Visits in Participants Not on Tafamidis at Baseline
|
0.997 hazard ratio
|
—
|
SECONDARY outcome
Timeframe: Up to Month 12Population: All the participants from the Full Analysis Set \[all randomized participants who received any amount of study drug (either placebo or patisiran)\] were included in the data analysis for the outcome measure as pre-specified in the study protocol.
The hazard rate of all-cause mortality and all-cause hospitalizations and urgent HF visits was compared between treatment groups using a modified Andersen-Gill model. A hazard ratio \<1 represents a favorable outcome for patisiran.
Outcome measures
| Measure |
Placebo (DB)/Patisiran (OLE)
n=359 Participants
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Patisiran (DB+OLE)
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period. Participants will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|
|
Composite Endpoint of All-cause Mortality and Frequency of All-cause Hospitalizations and Urgent HF Visits in All Participants
|
0.883 hazard ratio
|
—
|
Adverse Events
Double-blind Period: Placebo
Serious events: 63 serious events
Other events: 168 other events
Deaths: 8 deaths
Double-blind Period: Patisiran
Serious events: 61 serious events
Other events: 165 other events
Deaths: 4 deaths
Open Label Extension Period: Placebo (in DB Period) to Patisiran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Open Label Extension Period: Patisiran (in DB Period) to Patisiran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Double-blind Period: Placebo
n=178 participants at risk
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period.
|
Double-blind Period: Patisiran
n=181 participants at risk
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period.
|
Open Label Extension Period: Placebo (in DB Period) to Patisiran
n=166 participants at risk
Participants who received placebo in DB period will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Open Label Extension Period: Patisiran (in DB Period) to Patisiran
n=168 participants at risk
Participants who received patisiran in DB period will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Angina unstable
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
4/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
2.8%
5/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrioventricular block complete
|
2.2%
4/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Cardiac failure
|
7.3%
13/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
8.3%
15/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Conduction disorder
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
3/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Pericarditis
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Enteritis
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Asthenia
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Chest discomfort
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Chest pain
|
1.7%
3/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Pyrexia
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Vessel puncture site haematoma
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Immune system disorders
Amyloidosis
|
2.2%
4/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Immune system disorders
Drug hypersensitivity
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Appendicitis
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
COVID-19
|
1.7%
3/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Cellulitis
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Dengue fever
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Diverticulitis
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Infected bite
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Pneumonia
|
1.7%
3/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Investigations
Blood ethanol increased
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Investigations
Heart rate irregular
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Investigations
Troponin I increased
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
3/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinom
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.7%
3/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Seizure
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Syncope
|
2.2%
4/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.1%
2/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Renal and urinary disorders
Haematuria
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.56%
1/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.55%
1/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
Other adverse events
| Measure |
Double-blind Period: Placebo
n=178 participants at risk
Participants were administered placebo IV every 3 weeks during the 12-month double-blind (DB) treatment period.
|
Double-blind Period: Patisiran
n=181 participants at risk
Participants were administered patisiran 0.3 mg/kg intravenously (IV) every 3 weeks during the 12-month DB treatment period.
|
Open Label Extension Period: Placebo (in DB Period) to Patisiran
n=166 participants at risk
Participants who received placebo in DB period will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month open label extension (OLE) period.
|
Open Label Extension Period: Patisiran (in DB Period) to Patisiran
n=168 participants at risk
Participants who received patisiran in DB period will be administered patisiran 0.3 mg/kg IV every 3 weeks during the 36-month OLE period.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
38.2%
68/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
29.8%
54/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Immune system disorders
Infusion related reaction
|
9.0%
16/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
12.2%
22/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Constipation
|
10.7%
19/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
11.0%
20/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
14.6%
26/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
8.8%
16/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
14/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
8.3%
15/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
COVID-19
|
14.0%
25/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
7.7%
14/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
8/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
7.7%
14/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
General disorders
Fatigue
|
8.4%
15/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
6.6%
12/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
12/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
6.6%
12/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
4/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
6.6%
12/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Metabolism and nutrition disorders
Gout
|
6.7%
12/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
6.1%
11/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
8.4%
15/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.5%
10/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
12/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.5%
10/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Psychiatric disorders
Insomnia
|
6.2%
11/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.5%
10/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
5/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.5%
10/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Dizziness
|
8.4%
15/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.0%
9/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
7/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
5.0%
9/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Syncope
|
7.3%
13/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
4.4%
8/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
9/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
4.4%
8/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Nervous system disorders
Headache
|
6.2%
11/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
3.3%
6/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
|
Vascular disorders
Orthostatic hypotension
|
5.1%
9/178 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
1.7%
3/181 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/166 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
0.00%
0/168 • All-cause mortality: From the first dose of study drug up to data cut-off (approximately 17.5 months); Adverse events: From the first dose of study drug up to the end of double-blind treatment period (approximately 12 months)
Deaths and adverse events collected during the double-blind treatment period were reported. Open-label extension (OLE) period of the study is ongoing and the results will be posted after study completion. In all-cause mortality, all deaths occurred in study due to any cause are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It is intended that after completion of the study, the data are to be submitted for publication in a scientific journal and/or for reporting at a scientific meeting. A copy of any proposed publication (eg, manuscript, abstracts, oral/slide presentations, book chapters) based on this study, must be provided and confirmed received at the Sponsor at least 30 days before its submission. The Clinical Trial Agreement will detail the procedures for publications.
- Publication restrictions are in place
Restriction type: OTHER