Trial Outcomes & Findings for A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes (NCT NCT05254002)
NCT ID: NCT05254002
Last Updated: 2026-07-13
Results Overview
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1664 participants
Primary outcome timeframe
Baseline and Day 180
Results posted on
2026-07-13
Participant Flow
A total of 1664 participants were screened and signed the informed consent form for the study. 846 participants were screen failures and did not complete screening. The study was conducted at 163 centers in 14 countries/regions across Asia, Europe and North America from 23 Jun 2022 (First Patient First Visit) to 17 Mar 2025 (Last Patient Last Visit).
Overall, 818 participants were randomized. Of these, 14 participants were prospectively excluded from the analyses because of Good Clinical Practice (GCP) violations, 4 participants were excluded from the FAS (Full Analysis Set) because they were mis-randomized and did not take at least one dose of treatment. FAS and SAF (Safety Analysis Set) differed by only 2 participants who never received any study intervention.
Participant milestones
| Measure |
Finerenone and Empagliflozin
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
Finerenone and Empagliflozin Placebo
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days
|
Empagliflozin and Finerenone Placebo
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
273
|
273
|
272
|
|
Overall Study
Treated
|
271
|
270
|
271
|
|
Overall Study
Included in Full Analysis Set (FAS)
|
269
|
264
|
267
|
|
Overall Study
Included in Safety Analysis Set (SAF)
|
268
|
264
|
266
|
|
Overall Study
COMPLETED
|
240
|
232
|
238
|
|
Overall Study
NOT COMPLETED
|
33
|
41
|
34
|
Reasons for withdrawal
| Measure |
Finerenone and Empagliflozin
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
Finerenone and Empagliflozin Placebo
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days
|
Empagliflozin and Finerenone Placebo
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
11
|
10
|
|
Overall Study
Death
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
5
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
12
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
3
|
|
Overall Study
Randomized by mistake
|
1
|
0
|
2
|
|
Overall Study
Other reasons
|
1
|
4
|
1
|
|
Overall Study
GCP violation
|
3
|
6
|
5
|
|
Overall Study
Never took study drug
|
2
|
3
|
1
|
Baseline Characteristics
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Finerenone and Empagliflozin
n=269 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days
|
Empagliflozin and Finerenone Placebo
n=267 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 10.0 • n=20 Participants
|
65.5 years
STANDARD_DEVIATION 10.7 • n=20 Participants
|
66.2 years
STANDARD_DEVIATION 10.1 • n=40 Participants
|
66.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
70 Participants
n=40 Participants
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=20 Participants
|
203 Participants
n=20 Participants
|
197 Participants
n=40 Participants
|
602 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
239 Participants
n=20 Participants
|
235 Participants
n=20 Participants
|
238 Participants
n=40 Participants
|
712 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
114 Participants
n=20 Participants
|
132 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
371 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=20 Participants
|
105 Participants
n=20 Participants
|
116 Participants
n=40 Participants
|
351 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 180Population: This outcome was analyzed using the Full Analysis Set (FAS). Only participants with non-missing outcome data at the corresponding visit were included.
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures. The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=238 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=240 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone
|
0.708 ratio
Interval 0.636 to 0.789
|
—
|
0.483 ratio
Interval 0.435 to 0.537
|
PRIMARY outcome
Timeframe: Baseline and Day 180Population: This outcome was analyzed using the Full Analysis Set (FAS). Only participants with non-missing outcome data at the corresponding visit were included.
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=236 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=240 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone
|
0.683 Ratio
Interval 0.613 to 0.761
|
—
|
0.483 Ratio
Interval 0.435 to 0.537
|
SECONDARY outcome
Timeframe: Up to 210 daysPopulation: This outcome was analyzed using the Full Analysis Set (FAS). Only participants with non-missing outcome data at the corresponding visit were included.
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 210 (30 days after stopping the treatment) relative to Day 180, estimated using a mixed model for repeated measures. A ratio above 1 indicates an increase in UACR at Day 210 compared with Day 180. UACR is a measurement of albuminuria, a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=234 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=238 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=239 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180
|
1.448 ratio
Interval 1.323 to 1.585
|
1.442 ratio
Interval 1.318 to 1.577
|
1.631 ratio
Interval 1.493 to 1.782
|
SECONDARY outcome
Timeframe: Baseline to Day 210 (30 days after End of Treatment)Population: This outcome was analyzed using the Full Analysis Set (FAS). Only participants with non-missing outcome data at the corresponding visit were included.
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) relative to baseline, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=230 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=235 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=234 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline
|
0.853 ratio
Interval 0.762 to 0.956
|
0.895 ratio
Interval 0.801 to 1.0
|
0.818 ratio
Interval 0.734 to 0.911
|
SECONDARY outcome
Timeframe: At Day 180Population: This outcome was analysed using the Full Analysis Set (FAS). The denominator represents all participants at risk for the event of interest, defined as participants who had both a baseline and at least one post-baseline assessment, with baseline values within the expected biological plausibility range for the specified criterion. The numerator represents the number of participants whose relative change from baseline in UACR met the specified category threshold at Day 180.
This outcome summarizes the number of participants whose relative change from baseline in urine albumin-to-creatinine ratio (UACR) at Day 180 met prespecified category thresholds (\>30%, \>40%, or \>50%). Relative change was assessed based on baseline and post-baseline UACR measurements. Percentages were calculated using as denominator the number of participants with both a baseline and at least one post-baseline UACR assessment within the specified timeframe. Participants were classified independently within each category.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=236 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=238 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=240 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
Participants with relative change from baseline in UACR >30% at Day 180
|
123 Participants
|
123 Participants
|
168 Participants
|
|
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
Participants with relative change from baseline in UACR >40% at Day 180
|
104 Participants
|
103 Participants
|
154 Participants
|
|
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
Participants with relative change from baseline in UACR >50% at Day 180
|
84 Participants
|
76 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: At Day 30Population: This outcome was analyzed using the Safety Analysis Set (SAF). Only participants with non-missing outcome data at the corresponding visit were included
Change from baseline to Day 30 in estimated glomerular filtration rate (eGFR) was evaluated for each treatment group. Change was calculated as the value at Day 30 minus the baseline value. Negative values indicate a decrease from baseline and positive values indicate an increase from baseline.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=251 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=255 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=261 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Change From Baseline in eGFR at 30 Days
|
-2.036 mL/min/1.73 m^2
Interval -3.131 to -0.941
|
-3.788 mL/min/1.73 m^2
Interval -4.878 to -2.698
|
-5.593 mL/min/1.73 m^2
Interval -6.669 to -4.517
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline
|
10 Participants
|
3 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At Day 180 and Day 210Population: This outcome was analyzed using the Safety Analysis Set (SAF). Only participants with non-missing outcome data at the corresponding visit were included.
Change in estimated glomerular filtration rate (eGFR) from Day 30 to Day 180 and Day 210 was evaluated for each treatment group. Change was calculated as the value at Day 180 or Day 210 minus the value at Day 30. Positive values indicate an increase from Day 30 and negative values indicate a decrease from Day 30.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Change in eGFR at 180 Days and 210 Days From Day 30
Day 180
|
-0.285 mL/min/1.73 m^2
Interval -1.487 to 0.917
|
1.255 mL/min/1.73 m^2
Interval 0.107 to 2.402
|
0.874 mL/min/1.73 m^2
Interval -0.266 to 2.015
|
|
Change in eGFR at 180 Days and 210 Days From Day 30
Day 210
|
0.953 mL/min/1.73 m^2
Interval -0.264 to 2.17
|
3.976 mL/min/1.73 m^2
Interval 2.826 to 5.126
|
5.120 mL/min/1.73 m^2
Interval 3.993 to 6.247
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
AKI is defined as any of the following: * An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or * An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * A urine volume less than 0.5 ml/kg/h for 6 hours Total number of AKI events Up to 180 days
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With AKI Events
|
3 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
AKI is defined as any of the following: * An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or * An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * A urine volume less than 0.5 ml/kg/h for 6 hours Total number of AKI events Up to 180 days
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Total Number of AKI Events
|
3 events
|
0 events
|
5 events
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome used the SAF (all treated participants with ≥1 post-baseline potassium measurement). The Number Analyzed for each category includes participants with ≥1 post-baseline measurement who were at risk, excluding those whose baseline already met the threshold (\>5.5 mmol/L for moderate, \>6.0 mmol/L for severe). As exclusions are applied separately, the populations differ; therefore, severe is not a subset of moderate.
Moderate hyperkalemia was defined as K+ \>5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ \>6.0 mmol/L).
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])
Moderate Hyperkalemia Events (K+ >5.5 mmol/L to ≤6.0 mmol/L)
|
40 Participants
|
20 Participants
|
33 Participants
|
|
Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])
Severe Hyperkalemia Events (K+ >6.0 mmol/L)
|
12 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At baseline, day 14 and day 180Population: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment. The number of participants analyzed may differ across visits as only participants with available baseline and corresponding post-baseline serum potassium measurements at each scheduled time point contributed to the analysis.
Serum potassium values (mmol/L) were assessed at baseline and scheduled post-baseline visits. Results are presented as observed mean potassium concentrations at each time point.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Change From Baseline in K+
Baseline
|
4.51 mmol/L
Standard Deviation 0.46
|
4.52 mmol/L
Standard Deviation 0.41
|
4.42 mmol/L
Standard Deviation 0.39
|
|
Change From Baseline in K+
Day 14
|
4.70 mmol/L
Standard Deviation 0.51
|
4.53 mmol/L
Standard Deviation 0.41
|
4.68 mmol/L
Standard Deviation 0.48
|
|
Change From Baseline in K+
Day 180
|
4.68 mmol/L
Standard Deviation 0.54
|
4.55 mmol/L
Standard Deviation 0.48
|
4.67 mmol/L
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Number of participants who experienced at least one symptomatic hypotension event during the study period
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Symptomatic Hypotension Events
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Symptomatic hypotension events were assessed at all study visits and were documented as adverse events. The outcome represents the total number of symptomatic hypotension events reported during the study period.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Total Number of Symptomatic Hypotension Events
|
0 events
|
0 events
|
3 events
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Genital Mycotic Events
|
0 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Total Number of Genital Mycotic Events
|
0 events
|
6 events
|
4 events
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Urosepsis and Pyelonephritis Events
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Total Number of Urosepsis and Pyelonephritis Events
|
0 events
|
1 events
|
2 events
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Ketoacidosis Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Total Number of Ketoacidosis Events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Necrotizing Fasciitis of the Perineum Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: This outcome was analyzed using the Safety Analysis Set (SAF), which includes all participants who received at least one dose of study treatment.
Severe hypoglycemia was defined as glucose level of \<3.0 mmol/L (\<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia. In addition, severe hypoglycemia, as defined by the ADA denotes severe cognitive impairment requiring external assistance for recovery.
Outcome measures
| Measure |
Finerenone and Empagliflozin Placebo
n=264 Participants
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin and Finerenone Placebo
n=266 Participants
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Finerenone and Empagliflozin
n=268 Participants
Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days
|
|---|---|---|---|
|
Number of Participants With Severe Hypoglycemia Events
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Finerenone + Empagliflozin Group
Serious events: 19 serious events
Other events: 141 other events
Deaths: 3 deaths
Finerenone Group
Serious events: 16 serious events
Other events: 136 other events
Deaths: 0 deaths
Empagliflozin Group
Serious events: 17 serious events
Other events: 129 other events
Deaths: 3 deaths
Never Received Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Finerenone + Empagliflozin Group
n=268 participants at risk
Participants took Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days.
|
Finerenone Group
n=264 participants at risk
Participants took Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin Group
n=266 participants at risk
Participants took Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Never Received Treatment
n=2 participants at risk
Participants were randomized to one of the groups but never received study intervention.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Epiretinal membrane
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Chest pain
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Death
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Cardiac death
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Kidney infection
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Toe amputation
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Finerenone + Empagliflozin Group
n=268 participants at risk
Participants took Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days.
|
Finerenone Group
n=264 participants at risk
Participants took Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
|
Empagliflozin Group
n=266 participants at risk
Participants took Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD) for up to 180 days.
|
Never Received Treatment
n=2 participants at risk
Participants were randomized to one of the groups but never received study intervention.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
5/268 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Hyperglobulinaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Goitre
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blepharitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Diabetic retinopathy
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Glaucoma
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Macular oedema
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Pigmentary maculopathy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eyelid haematoma
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
5/268 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.9%
5/266 • Number of events 6 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
9/268 • Number of events 10 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
3.4%
9/264 • Number of events 12 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.3%
6/266 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Faeces hard
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.9%
5/264 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Brunner's gland hyperplasia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Asthenia
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Chest pain
|
0.75%
2/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Fatigue
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.7%
7/264 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Influenza like illness
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Oedema
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Pain
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Pyrexia
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.9%
5/264 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Peripheral swelling
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders and administration site conditions
Early satiety
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
1.9%
5/268 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
1.1%
3/268 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Fungal infection
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.7%
7/264 • Number of events 9 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.1%
11/266 • Number of events 15 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Periodontitis
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tinea pedis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
5/268 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.3%
6/266 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
6/268 • Number of events 6 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
3.0%
8/266 • Number of events 9 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Genital infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Genital infection bacterial
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Genital infection fungal
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral rhinitis
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Latent tuberculosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.9%
5/266 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.37%
1/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.75%
2/268 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
2.6%
7/268 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood potassium increased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood pressure decreased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood sodium decreased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Cardiac murmur
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
6.3%
17/268 • Number of events 18 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.2%
11/264 • Number of events 11 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
3.8%
10/266 • Number of events 10 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Glomerular filtration rate increased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/266 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Transaminases increased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Blood ketone body increased
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Stool DNA test positive
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.3%
25/268 • Number of events 33 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
10.2%
27/264 • Number of events 31 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
3.8%
10/266 • Number of events 12 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
5/268 • Number of events 6 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic dyslipidaemia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.7%
7/264 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
3.4%
9/268 • Number of events 9 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
3.0%
8/264 • Number of events 8 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.6%
7/266 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
5/268 • Number of events 5 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Organic erectile dysfunction
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Penile dermatitis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
4/264 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.75%
2/268 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.75%
2/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
3/268 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
4/268 • Number of events 4 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.1%
3/266 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.76%
2/264 • Number of events 3 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Osteotomy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Cataract operation
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Hearing aid therapy
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
2.6%
7/268 • Number of events 7 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/268 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.38%
1/264 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.37%
1/268 • Number of events 1 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/264 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/266 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality was assessed from the randomization through the end of follow-up (up to 210 days). Serious and other adverse events were assessed from the first dose through the end of follow-up, including the treatment period (approximately 180 days) and the post-treatment follow-up period up to 30 days after the last dose (Day 210).
The Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER