Trial Outcomes & Findings for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (NCT NCT04153149)
NCT ID: NCT04153149
Last Updated: 2026-01-12
Results Overview
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participants who dropped out early for the primary analysis of this composite outcome endpoint.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
655 participants
Primary outcome timeframe
Up to Month 36
Results posted on
2026-01-12
Participant Flow
A total of 655 participants with hereditary amyloid transthyretin (hATTR) amyloidosis or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy took part in the study at 87 sites across 26 countries in North America, South America, Europe, Asia, and Australia. This study is still ongoing.
The study consists of 2 parts: Double-blind (DB) Period and Open-label Treatment Extension (OLE) Period. In the DB period, participants were randomized in a 1:1 ratio to receive vutrisiran or placebo and during the OLE Period, all participants receive vutrisiran. The DB period of the study has been completed while OLE period is still ongoing.
Participant milestones
| Measure |
DB Period: Placebo
Participants in the DB period received vutrisiran matching placebo, subcutaneous (SC) injection, once every 3 months (q3M) for up to 36 months.
|
DB Period: Vutrisiran
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
OLE Period: Placebo/Vutrisiran
Participants who received placebo in the DB period receive vutrisiran, 25 mg, SC injection, q3M for up to 24 months in the OLE period.
|
OLE Period: Vutrisiran/Vutrisiran
Participants who received vutrisiran 25 mg in the DB period continue receiving vutrisiran, 25 mg, SC injection, q3M for up to 24 months in the OLE period.
|
|---|---|---|---|---|
|
Double Blind Period
STARTED
|
329
|
326
|
0
|
0
|
|
Double Blind Period
COMPLETED
|
235
|
257
|
0
|
0
|
|
Double Blind Period
NOT COMPLETED
|
94
|
69
|
0
|
0
|
|
Open Label Extension Period
STARTED
|
0
|
0
|
221
|
241
|
|
Open Label Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open Label Extension Period
NOT COMPLETED
|
0
|
0
|
221
|
241
|
Reasons for withdrawal
| Measure |
DB Period: Placebo
Participants in the DB period received vutrisiran matching placebo, subcutaneous (SC) injection, once every 3 months (q3M) for up to 36 months.
|
DB Period: Vutrisiran
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
OLE Period: Placebo/Vutrisiran
Participants who received placebo in the DB period receive vutrisiran, 25 mg, SC injection, q3M for up to 24 months in the OLE period.
|
OLE Period: Vutrisiran/Vutrisiran
Participants who received vutrisiran 25 mg in the DB period continue receiving vutrisiran, 25 mg, SC injection, q3M for up to 24 months in the OLE period.
|
|---|---|---|---|---|
|
Double Blind Period
Death
|
63
|
49
|
0
|
0
|
|
Double Blind Period
Withdrawal by Subject
|
16
|
11
|
0
|
0
|
|
Double Blind Period
Adverse Event
|
6
|
2
|
0
|
0
|
|
Double Blind Period
Lost to Follow-up
|
2
|
1
|
0
|
0
|
|
Double Blind Period
Withdrawal by guardian
|
0
|
2
|
0
|
0
|
|
Double Blind Period
Reason Not Specified
|
5
|
4
|
0
|
0
|
|
Double Blind Period
Physician Decision
|
2
|
0
|
0
|
0
|
|
Open Label Extension Period
Death
|
0
|
0
|
7
|
3
|
|
Open Label Extension Period
Withdrawal by guardian
|
0
|
0
|
1
|
0
|
|
Open Label Extension Period
Participant Withdrew from Treatment but Ongoing in Safety Follow-up
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period
Study Treatment Ongoing
|
0
|
0
|
213
|
237
|
Baseline Characteristics
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Baseline characteristics by cohort
| Measure |
DB Period: Placebo
n=328 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
DB Period: Vutrisiran
n=326 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.2 years
STANDARD_DEVIATION 6.3 • n=210 Participants
|
75.5 years
STANDARD_DEVIATION 7.2 • n=19 Participants
|
75.4 years
STANDARD_DEVIATION 6.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=210 Participants
|
27 Participants
n=19 Participants
|
49 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
306 Participants
n=210 Participants
|
299 Participants
n=19 Participants
|
605 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=210 Participants
|
22 Participants
n=19 Participants
|
38 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
304 Participants
n=210 Participants
|
298 Participants
n=19 Participants
|
602 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=210 Participants
|
18 Participants
n=19 Participants
|
37 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=210 Participants
|
23 Participants
n=19 Participants
|
47 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
275 Participants
n=210 Participants
|
277 Participants
n=19 Participants
|
552 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
8 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Month 36Population: FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo).
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participants who dropped out early for the primary analysis of this composite outcome endpoint.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=326 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=328 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population
|
125 Participants
|
159 Participants
|
PRIMARY outcome
Timeframe: Up to Month 36Population: Vutrisiran Monotherapy Subgroup FAS included all participants who were not on tafamidis at the study baseline in the FAS. FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo).
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participants who dropped out early for the primary analysis of this composite outcome endpoint.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=196 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=199 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup
|
76 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 30Population: FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo). Overall number analyzed is the number of participants with data available for analysis.
The 6-MWT is an assessment of functional exercise capacity. Participants are instructed to walk back and forth along a flat, straight path, typically 30 meters in length, for a duration of 6 minutes. The total distance covered in meters is recorded at the end of 6 minutes. A longer distance reflects a better outcome. Analysis was based on the mixed-effect model of repeated measures (MMRM). Missing change values due to amyloidosis disease progression and death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the statistical analysis plan (SAP).
Outcome measures
| Measure |
DB Period: Vutrisiran
n=325 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=328 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Change From Baseline in 6-Minute Walk Test (6-MWT) in the Overall Population
|
-45.42 meters
Standard Error 4.62
|
-71.88 meters
Standard Error 4.79
|
SECONDARY outcome
Timeframe: Baseline to Month 30Population: Vutrisiran Monotherapy Subgroup FAS included all participants who were not on tafamidis at the study baseline in the FAS. FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo).
The 6-MWT is an assessment of functional exercise capacity. Participants are instructed to walk back and forth along a flat, straight path, typically 30 meters in length, for a duration of 6 minutes. The total distance covered in meters is recorded at the end of 6 minutes. A longer distance reflects a better outcome. Analysis was based on the MMRM. Missing change values due to amyloidosis disease progression and death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the SAP.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=196 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=199 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Change From Baseline in 6-MWT in the Vutrisiran Monotherapy Subgroup
|
-59.69 meters
Standard Error 6.60
|
-91.78 meters
Standard Error 6.39
|
SECONDARY outcome
Timeframe: Baseline to Month 30Population: FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo). Overall number analyzed is the number of participants with data available for analysis.
The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms \[frequency and burden\], physical function, quality of life (QoL), social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \[OS\]). Scores were generated for each domain and transformed to a range of 0-100, in which higher scores reflect better health status. KCCQ- overall summary score was average of domains- physical function, total symptoms (average of symptom frequency and burden), QoL, and social limitation, and transformed to a single score which ranged from 0 (worst) - 100 (the best possible status), where the higher score reflected better health status. Analysis was based on the MMRM.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=325 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=327 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Score in the Overall Population
|
-9.68 score on a scale
Standard Error 1.19
|
-15.49 score on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline to Month 30Population: Vutrisiran Monotherapy Subgroup FAS included all participants who were not on tafamidis at the study baseline in the FAS. Overall number analyzed is the number of participants with data available for analysis.
The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms \[frequency and burden\], physical function, QoL, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and OS). Scores were generated for each domain and transformed to a range of 0-100, in which higher scores reflect better health status. KCCQ- overall summary score was average of domains- physical function, total symptoms (average of symptom frequency and burden), QoL, and social limitation, and transformed to a single score which ranged from 0 (worst) - 100 (the best possible status), where the higher score reflected better health status. Analysis was based on the MMRM.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=195 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=198 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Change From Baseline in the KCCQ-OS Score in the Vutrisiran Monotherapy Subgroup
|
-10.78 score on a scale
Standard Error 1.66
|
-19.47 score on a scale
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Up to 42 monthsAll-cause mortality also included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 30Population: FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo).
NYHA class is a clinical assessment of symptoms resulting from heart failure. In NYHA functional classification system places participants in 1 of 4 categories based on limitations of physical activity. Class I denotes no symptoms and no limitation of physical activity; II, slight limitation, resulting in symptoms with ordinary physical activity; III, marked limitation, resulting in symptoms with less than ordinary physical activity; and IV, symptoms at rest. Here, the participants with a change in NYHA class have been reported in two categories: 1\) participants who had no change or had improvement in the NYHA class (lower class) from baseline and 2) participants who had a worsened NYHA class from baseline (higher class). Values have been rounded off to a single decimal.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=326 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=328 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Percentage of Participants With Change in NYHA Class at Month 30 in the Overall Population
Stable or improved from baseline
|
67.8 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants With Change in NYHA Class at Month 30 in the Overall Population
Worsened from baseline
|
32.2 percentage of participants
|
39.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 30Population: Vutrisiran Monotherapy Subgroup FAS included all participants who were not on tafamidis at the study baseline in the FAS.
NYHA class is a clinical assessment of symptoms resulting from heart failure. In NYHA functional classification system places participants in 1 of 4 categories based on limitations of physical activity. Class I denotes no symptoms and no limitation of physical activity; II, slight limitation, resulting in symptoms with ordinary physical activity; III, marked limitation, resulting in symptoms with less than ordinary physical activity; and IV, symptoms at rest. Here, the participants with a change in NYHA class have been reported in two categories: 1\) participants who had no change or had improvement in the NYHA class (lower class) from baseline and 2) participants who had a worsened NYHA class from baseline (higher class). Values have been rounded off to a single decimal.
Outcome measures
| Measure |
DB Period: Vutrisiran
n=196 Participants
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
DB Period: Placebo
n=199 Participants
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Percentage of Participants With Change in NYHA Class at Month 30 in the Vutrisiran Monotherapy Subgroup
Stable or improved from baseline
|
66.3 percentage of participants
|
56.4 percentage of participants
|
|
Percentage of Participants With Change in NYHA Class at Month 30 in the Vutrisiran Monotherapy Subgroup
Worsened from baseline
|
33.7 percentage of participants
|
43.6 percentage of participants
|
Adverse Events
DB Period: Placebo
Serious events: 220 serious events
Other events: 303 other events
Deaths: 63 deaths
DB Period: Vutrisiran
Serious events: 201 serious events
Other events: 293 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
DB Period: Placebo
n=328 participants at risk
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
DB Period: Vutrisiran
n=326 participants at risk
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Angina pectoris
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Angina unstable
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Arrhythmia
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
20/328 • Number of events 27 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
8.0%
26/326 • Number of events 29 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial flutter
|
2.7%
9/328 • Number of events 9 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.8%
9/326 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial tachycardia
|
0.91%
3/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial thrombosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrioventricular block
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.5%
5/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.8%
6/326 • Number of events 6 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Bifascicular block
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Bradycardia
|
2.1%
7/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.91%
3/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure
|
17.4%
57/328 • Number of events 94 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
11.7%
38/326 • Number of events 70 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure acute
|
5.5%
18/328 • Number of events 21 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.0%
13/326 • Number of events 16 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.6%
15/328 • Number of events 21 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiogenic shock
|
2.1%
7/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Conduction disorder
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Left ventricular failure
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Palpitations
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Pericardial effusion
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Tachycardia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.4%
8/328 • Number of events 9 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.5%
8/326 • Number of events 9 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Endocrine disorders
Hyperthyroidism
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Eye disorders
Cataract
|
0.30%
1/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Eye disorders
Visual impairment
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Ascites
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Constipation
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Haematochezia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Ileus
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Asthenia
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Cardiac death
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Chest pain
|
2.1%
7/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Complication associated with device
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Death
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Disease progression
|
1.5%
5/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Drowning
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Fatigue
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
General physical health deterioration
|
0.30%
1/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Generalised oedema
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Hernia pain
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Implant site haematoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Non-cardiac chest pain
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Oedema
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Oedema peripheral
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Organ failure
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Peripheral swelling
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Physical deconditioning
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Pyrexia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Arthritis bacterial
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Bacteraemia
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Bacterial infection
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Bronchitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
COVID-19
|
1.5%
5/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Cellulitis
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Clostridium difficile infection
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Cystitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Cystitis escherichia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Device related infection
|
0.61%
2/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Diverticulitis
|
1.2%
4/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.30%
1/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Gastroenteritis viral
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Infectious pleural effusion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Infective corneal ulcer
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Influenza
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Medical device site infection
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Meningitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Pneumonia
|
3.0%
10/328 • Number of events 11 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
3.7%
12/326 • Number of events 13 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Post procedural infection
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Pyelonephritis
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Pyelonephritis acute
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Sepsis
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.8%
6/326 • Number of events 6 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Septic phlebitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Septic shock
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Sinusitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Soft tissue infection
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Spinal cord infection
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.8%
6/326 • Number of events 6 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Complications of transplanted heart
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
8/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.8%
6/326 • Number of events 6 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Flatback syndrome
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.30%
1/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Wound
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Cardiovascular evaluation
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Haemoglobin decreased
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Hepatic enzyme increased
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Investigations
Weight decreased
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
7/328 • Number of events 7 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
8/328 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
3.1%
10/326 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma metastatic
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.91%
3/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Haematoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage III
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.30%
1/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.61%
2/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Ataxia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebral infarction
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
4/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Dementia
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Embolic stroke
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Encephalopathy
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Ischaemic stroke
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Migraine
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Parkinson's disease
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Presyncope
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Seizure
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Syncope
|
2.1%
7/328 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.5%
8/326 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Product Issues
Device dislocation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Product Issues
Device malfunction
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Psychiatric disorders
Delirium
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
10/328 • Number of events 13 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
3.4%
11/326 • Number of events 12 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Haematuria
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Renal failure
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Renal impairment
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Renal tubular dysfunction
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Urethral perforation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
5/328 • Number of events 6 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
3/328 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
4/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
4/328 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.5%
5/326 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.61%
2/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.92%
3/326 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Cardioversion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Diverticulectomy
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Surgical and medical procedures
Wound treatment
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Aortic stenosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Atheroembolism
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Dry gangrene
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Hypotension
|
0.91%
3/328 • Number of events 3 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.5%
5/326 • Number of events 5 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Orthostatic hypotension
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.61%
2/328 • Number of events 2 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.30%
1/328 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.00%
0/326 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/328 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
0.31%
1/326 • Number of events 1 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
Other adverse events
| Measure |
DB Period: Placebo
n=328 participants at risk
Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months.
|
DB Period: Vutrisiran
n=326 participants at risk
Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
16/328 • Number of events 16 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
5.8%
19/326 • Number of events 20 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial fibrillation
|
17.7%
58/328 • Number of events 65 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
18.1%
59/326 • Number of events 78 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Atrial flutter
|
5.2%
17/328 • Number of events 21 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
7.4%
24/326 • Number of events 26 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure
|
32.0%
105/328 • Number of events 161 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
24.2%
79/326 • Number of events 103 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Cardiac failure congestive
|
5.2%
17/328 • Number of events 18 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.5%
8/326 • Number of events 9 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Cardiac disorders
Palpitations
|
5.5%
18/328 • Number of events 18 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
1.2%
4/326 • Number of events 4 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Endocrine disorders
Hypothyroidism
|
5.2%
17/328 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
3.4%
11/326 • Number of events 11 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
42/328 • Number of events 53 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
10.1%
33/326 • Number of events 35 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
30/328 • Number of events 34 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.6%
15/326 • Number of events 16 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
26/328 • Number of events 28 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.8%
9/326 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Chest pain
|
7.0%
23/328 • Number of events 29 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
5.2%
17/326 • Number of events 20 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Fatigue
|
13.1%
43/328 • Number of events 56 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
8.3%
27/326 • Number of events 32 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
General disorders
Oedema peripheral
|
7.6%
25/328 • Number of events 28 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
10.1%
33/326 • Number of events 40 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
COVID-19
|
29.6%
97/328 • Number of events 104 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
26.4%
86/326 • Number of events 92 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Cellulitis
|
5.8%
19/328 • Number of events 21 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.9%
16/326 • Number of events 18 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Pneumonia
|
5.2%
17/328 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.6%
15/326 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
24/328 • Number of events 27 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.9%
16/326 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Infections and infestations
Urinary tract infection
|
11.0%
36/328 • Number of events 45 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
9.8%
32/326 • Number of events 44 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Fall
|
20.1%
66/328 • Number of events 103 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
12.0%
39/326 • Number of events 58 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.5%
18/328 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.0%
13/326 • Number of events 14 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Gout
|
15.5%
51/328 • Number of events 77 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
14.4%
47/326 • Number of events 78 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
6.4%
21/328 • Number of events 36 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.6%
15/326 • Number of events 16 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.6%
25/328 • Number of events 33 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.9%
16/326 • Number of events 18 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
38/328 • Number of events 45 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
10.1%
33/326 • Number of events 49 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
31/328 • Number of events 37 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
11.0%
36/326 • Number of events 41 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
24/328 • Number of events 28 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
6.1%
20/326 • Number of events 23 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
19/328 • Number of events 24 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.3%
14/326 • Number of events 15 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.3%
14/328 • Number of events 16 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
6.4%
21/326 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
32/328 • Number of events 48 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
8.3%
27/326 • Number of events 40 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.8%
19/328 • Number of events 20 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
3.1%
10/326 • Number of events 11 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Dizziness
|
13.1%
43/328 • Number of events 52 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
9.8%
32/326 • Number of events 36 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Headache
|
6.1%
20/328 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.8%
9/326 • Number of events 12 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Paraesthesia
|
5.5%
18/328 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.5%
8/326 • Number of events 8 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Nervous system disorders
Syncope
|
7.0%
23/328 • Number of events 29 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.3%
14/326 • Number of events 14 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Psychiatric disorders
Insomnia
|
6.7%
22/328 • Number of events 23 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
5.5%
18/326 • Number of events 18 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.8%
19/328 • Number of events 23 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
6.7%
22/326 • Number of events 25 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.2%
17/328 • Number of events 20 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.9%
16/326 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Renal and urinary disorders
Haematuria
|
7.9%
26/328 • Number of events 33 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
6.1%
20/326 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
27/328 • Number of events 28 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
7.4%
24/326 • Number of events 26 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.6%
48/328 • Number of events 61 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
12.9%
42/326 • Number of events 47 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
20/328 • Number of events 22 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.6%
15/326 • Number of events 17 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
21/328 • Number of events 24 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
4.0%
13/326 • Number of events 13 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
|
Vascular disorders
Hypotension
|
6.7%
22/328 • Number of events 23 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
2.5%
8/326 • Number of events 10 • Up to Month 36
Safety Analysis Set included all participants who received any amount of study drug. 1 participant randomized to placebo was not dosed and not included in the analysis. DB period is completed and data collected during the DB period are reported here. Data collection for the OLE period is still ongoing. Adverse event data for the OLE period will be reported one year after the study completion date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place