Trial Outcomes & Findings for Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis (NCT NCT00853242)
NCT ID: NCT00853242
Last Updated: 2015-05-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
349 participants
Primary outcome timeframe
Baseline, Day 22
Results posted on
2015-05-01
Participant Flow
The study was conducted at 64 centers in the United States between 11 February 2009 and 20 August 2009.
A total of 670 participants were screened of which 321 were screen failure and 349 participants were randomized. After screening, participants entered a two-week phosphate binder washout period prior to randomization.
Participant milestones
| Measure |
Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
|
Genz-644470 2.4 Grams Per Day (g/Day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
49
|
50
|
50
|
51
|
49
|
|
Overall Study
Treated
|
50
|
49
|
48
|
50
|
50
|
51
|
48
|
|
Overall Study
COMPLETED
|
47
|
47
|
46
|
46
|
46
|
49
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
4
|
4
|
2
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
|
Genz-644470 2.4 Grams Per Day (g/Day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
3
|
1
|
1
|
|
Overall Study
Noncompliant
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
4
|
0
|
0
|
2
|
|
Overall Study
Other
|
2
|
0
|
2
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=49 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=48 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=50 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 2.4 g/Day
n=50 Participants
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=51 Participants
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Total
n=346 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 13.4 • n=21 Participants
|
56.6 years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
53.6 years
STANDARD_DEVIATION 13.1 • n=8 Participants
|
56.2 years
STANDARD_DEVIATION 12.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
144 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
202 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
8 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
23 participants
n=21 Participants
|
25 participants
n=8 Participants
|
22 participants
n=8 Participants
|
161 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
25 participants
n=21 Participants
|
25 participants
n=8 Participants
|
23 participants
n=8 Participants
|
173 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Serum Phosphorus Level
less than (<) 7.0 milligram per deciliter (mg/dL)
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
21 participants
n=4 Participants
|
22 participants
n=21 Participants
|
20 participants
n=8 Participants
|
17 participants
n=8 Participants
|
145 participants
n=24 Participants
|
|
Serum Phosphorus Level
Greater Than or Equal to (>=) 7.0 mg/dL
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
29 participants
n=4 Participants
|
28 participants
n=21 Participants
|
31 participants
n=8 Participants
|
31 participants
n=8 Participants
|
201 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 22Population: Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (\<=) 3 days after date of last study drug.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=48 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=47 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=46 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
|
-0.0 mg/dL
Standard Deviation 1.3
|
-0.6 mg/dL
Standard Deviation 1.5
|
-1.2 mg/dL
Standard Deviation 1.6
|
-1.8 mg/dL
Standard Deviation 1.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure \<= 3 days after date of last study drug.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=47 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=46 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=49 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=48 Participants
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=47 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
|
-0.6 mg/dL
Standard Deviation 1.5
|
-1.2 mg/dL
Standard Deviation 1.6
|
-1.8 mg/dL
Standard Deviation 1.9
|
-0.9 mg/dL
Standard Deviation 1.7
|
-1.3 mg/dL
Standard Deviation 1.9
|
-2.0 mg/dL
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Full Analysis Set.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=48 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=47 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=46 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=49 Participants
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=47 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
|
-0.1 mg^2/dL^2
Standard Deviation 12.7
|
-4.5 mg^2/dL^2
Standard Deviation 12.3
|
-9.2 mg^2/dL^2
Standard Deviation 14.7
|
-16.1 mg^2/dL^2
Standard Deviation 16.1
|
-8.3 mg^2/dL^2
Standard Deviation 17.4
|
-10.3 mg^2/dL^2
Standard Deviation 17.5
|
-17.5 mg^2/dL^2
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Full Analysis Set.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=48 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=47 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=46 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=49 Participants
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=47 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol at Day 22
|
-3.8 mg/dL
Standard Deviation 20.9
|
-13.5 mg/dL
Standard Deviation 20.7
|
-11.2 mg/dL
Standard Deviation 19.7
|
-17.8 mg/dL
Standard Deviation 22.8
|
-2.9 mg/dL
Standard Deviation 17.1
|
-15.8 mg/dL
Standard Deviation 16.3
|
-18.1 mg/dL
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Full Analysis Set.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=48 Participants
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=47 Participants
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=46 Participants
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=49 Participants
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=47 Participants
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
|
-1.3 mg/dL
Standard Deviation 17.4
|
-15.4 mg/dL
Standard Deviation 19.8
|
-13.2 mg/dL
Standard Deviation 18.6
|
-21.9 mg/dL
Standard Deviation 23.5
|
-7.5 mg/dL
Standard Deviation 13.0
|
-17.7 mg/dL
Standard Deviation 14.8
|
-22.6 mg/dL
Standard Deviation 24.5
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Genz-644470 2.4 g/Day
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Genz-644470 4.8 g/Day
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Genz-644470 7.2 g/Day
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Sevelamer Carbonate 2.4 g/Day
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Sevelamer Carbonate 4.8 g/Day
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Sevelamer Carbonate 7.2 g/Day
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=49 participants at risk
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=48 participants at risk
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=50 participants at risk
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 2.4 g/Day
n=50 participants at risk
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=51 participants at risk
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 participants at risk
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Endocarditis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Arteriovenous graft site abscess
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Surgical and medical procedures
Renal transplant
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
|
Genz-644470 2.4 g/Day
n=49 participants at risk
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 4.8 g/Day
n=48 participants at risk
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Genz-644470 7.2 g/Day
n=50 participants at risk
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 2.4 g/Day
n=50 participants at risk
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 4.8 g/Day
n=51 participants at risk
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
|
Sevelamer Carbonate 7.2 g/Day
n=48 participants at risk
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.1%
2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.0%
3/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
8.3%
4/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.1%
3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.0%
3/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
14.6%
7/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Asthenia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Catheter related complication
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Catheter site swelling
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Face oedema
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Investigations
Heart rate irregular
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.1%
2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
8.0%
4/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
2.0%
1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER