Trial Outcomes & Findings for A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP (NCT NCT06362759)
NCT ID: NCT06362759
Last Updated: 2026-08-11
Results Overview
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Results posted on
2026-08-11
Participant Flow
Participants were recruited from 49 study centers in the United States between May 2024 and December 2024. Of 49 sites, 38 sites enrolled participants. The first participant was enrolled on May 15, 2024 and the last participant was enrolled on December 3, 2024.
Of the 454 initial and re-screenings (where applicable), 143 were randomized to receive treatment or placebo.
Participant milestones
| Measure |
Placebo
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
TOUR006 - 50 MG
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
36
|
36
|
|
Overall Study
Dosed
|
36
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
33
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
TOUR006 - 50 MG
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
4
|
4
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Eligibility Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=31 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
TOUR006 - 50 MG
n=30 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=34 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=54 Participants
|
73 years
n=54 Participants
|
70 years
n=27 Participants
|
65 years
n=26 Participants
|
71 years
n=161 Participants
|
|
Sex/Gender, Customized
Female
|
21 Participants
n=54 Participants
|
17 Participants
n=54 Participants
|
19 Participants
n=27 Participants
|
21 Participants
n=26 Participants
|
78 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=54 Participants
|
10 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
32 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=54 Participants
|
21 Participants
n=54 Participants
|
23 Participants
n=27 Participants
|
27 Participants
n=26 Participants
|
94 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=54 Participants
|
8 Participants
n=54 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=26 Participants
|
38 Participants
n=161 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=54 Participants
|
23 Participants
n=54 Participants
|
19 Participants
n=27 Participants
|
21 Participants
n=26 Participants
|
87 Participants
n=161 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=54 Participants
|
31 participants
n=54 Participants
|
30 participants
n=27 Participants
|
34 participants
n=26 Participants
|
126 participants
n=161 Participants
|
|
CKD Stage (IWRS)
CKD Stage 3 or UPCR ≥ 200 mg/g and eGFR ≥ 60 mL/min/1.73m2
|
26 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
25 Participants
n=27 Participants
|
30 Participants
n=26 Participants
|
108 Participants
n=161 Participants
|
|
CKD Stage (IWRS)
CKD Stage 4
|
5 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
18 Participants
n=161 Participants
|
|
hs-CRP, mg/L
|
3.60 mg/L
n=54 Participants
|
3.90 mg/L
n=54 Participants
|
5.18 mg/L
n=27 Participants
|
4.73 mg/L
n=26 Participants
|
4.45 mg/L
n=161 Participants
|
PRIMARY outcome
Timeframe: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.Population: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (modified-ITT)
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
Outcome measures
| Measure |
TOUR006 - 50 MG
n=30 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=34 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=31 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=31 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90
|
-85.7 Time-Averaged Percent Change in hsCRP
Interval -92.3 to -78.0
|
-84.7 Time-Averaged Percent Change in hsCRP
Interval -92.3 to -70.3
|
-14.8 Time-Averaged Percent Change in hsCRP
Interval -35.8 to 17.4
|
-75.2 Time-Averaged Percent Change in hsCRP
Interval -82.3 to -69.7
|
SECONDARY outcome
Timeframe: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.Population: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (modified-ITT)
Proportion of participants with time-averaged hs-CRP \< 2 mg/L (90 Days)
Outcome measures
| Measure |
TOUR006 - 50 MG
n=30 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=34 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=31 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=31 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)
|
24 Participants
|
30 Participants
|
8 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.Population: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (modified-ITT)
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 180. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 180 visits (approximately 150 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
Outcome measures
| Measure |
TOUR006 - 50 MG
n=30 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=34 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=31 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=31 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180
|
-85.3 Time-averaged percent change in hsCRP
Interval -93.1 to -72.2
|
-88.8 Time-averaged percent change in hsCRP
Interval -91.9 to -72.8
|
6.8 Time-averaged percent change in hsCRP
Interval -27.2 to 51.9
|
-76.4 Time-averaged percent change in hsCRP
Interval -82.1 to -65.9
|
SECONDARY outcome
Timeframe: Baseline through Day 365Population: Overall number analyzed includes all randomized participants who received at least one dose of pacibekitug and had sufficient valid PK concentrations to calculate at least one PK parameter. Participants were not analyzed at timepoints due to missed dose or missed visit, participants discontinuation, or no recorded dose on the previous visit, which is reflected in timepoint's "Number Analyzed."
Mean trough serum concentrations (ng/mL) of TOUR006 at Days 30, 60, 90,120, 150, 180, 240, 300, and 365. On dosing visits (BL and Day 30, 60, 90, 120, and 150 visits), PK samples were collected pre-dose. PK blood samples were collected on Study Days 180, 240, 300, and 365 at approximately the same time as the pre-dose samples were collected on previous dosing visits.
Outcome measures
| Measure |
TOUR006 - 50 MG
n=35 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=32 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=32 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 30
|
857.00 ng/mL
Standard Deviation 335.31
|
—
|
1347.86 ng/mL
Standard Deviation 544.50
|
2753.95 ng/mL
Standard Deviation 718.79
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 60
|
1473.06 ng/mL
Standard Deviation 559.41
|
—
|
964.92 ng/mL
Standard Deviation 345.99
|
1735.04 ng/mL
Standard Deviation 597.82
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 90
|
1830.07 ng/mL
Standard Deviation 742.07
|
—
|
668.35 ng/mL
Standard Deviation 257.77
|
1117.06 ng/mL
Standard Deviation 416.79
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 120
|
1963.65 ng/mL
Standard Deviation 799.95
|
—
|
1999.28 ng/mL
Standard Deviation 692.93
|
3502.15 ng/mL
Standard Deviation 1129.17
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 150
|
2031.46 ng/mL
Standard Deviation 986.05
|
—
|
1361.08 ng/mL
Standard Deviation 507.40
|
2098.06 ng/mL
Standard Deviation 680.55
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 180
|
2067.92 ng/mL
Standard Deviation 909.09
|
—
|
872.10 ng/mL
Standard Deviation 322.20
|
1383.64 ng/mL
Standard Deviation 609.80
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 240
|
1025.93 ng/mL
Standard Deviation 610.17
|
—
|
395.98 ng/mL
Standard Deviation 197.27
|
566.17 ng/mL
Standard Deviation 371.68
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 300
|
419.44 ng/mL
Standard Deviation 333.82
|
—
|
180.37 ng/mL
Standard Deviation 131.07
|
241.66 ng/mL
Standard Deviation 200.18
|
|
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Day 365
|
164.45 ng/mL
Standard Deviation 171.32
|
—
|
62.53 ng/mL
Standard Deviation 89.77
|
87.27 ng/mL
Standard Deviation 106.79
|
SECONDARY outcome
Timeframe: Baseline through Day 365.Population: Includes all randomized participants who received any amount of study treatment.
Evaluates the percentage of participants with treatment emergent adverse events (AE), which includes serious and nonserious AEs. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.
Outcome measures
| Measure |
TOUR006 - 50 MG
n=35 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=35 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=36 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=35 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
|
21 Participants
|
21 Participants
|
23 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 365.Population: Includes all randomized participants who received any amount of study treatment.
Evaluates the percentage of participants with serious treatment emergent adverse events. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.
Outcome measures
| Measure |
TOUR006 - 50 MG
n=35 Participants
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=35 Participants
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
Placebo
n=36 Participants
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=35 Participants
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
|---|---|---|---|---|
|
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
|
6 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
TOUR006 - 25 MG
Serious events: 7 serious events
Other events: 21 other events
Deaths: 1 deaths
TOUR006 - 50 MG
Serious events: 6 serious events
Other events: 21 other events
Deaths: 1 deaths
TOUR006 - 15 MG
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=35 participants at risk
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
TOUR006 - 50 MG
n=35 participants at risk
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=35 participants at risk
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Necrotising Fasciitis Streptococcal
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Wound Cellulitis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Bradycardia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Renal Pain
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Arachnoid Cyst
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo: Placebo
|
TOUR006 - 25 MG
n=35 participants at risk
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG: TOUR006 25 MG
|
TOUR006 - 50 MG
n=35 participants at risk
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG: TOUR006 50 MG
|
TOUR006 - 15 MG
n=35 participants at risk
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG: TOUR006 15 MG
|
|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Ear Infection
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
4/36 • Number of events 4 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
11.4%
4/35 • Number of events 5 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
2/36 • Number of events 4 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Bronchitis
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
8.6%
3/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
8.6%
3/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
2/36 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
5.7%
2/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Sinusitis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Anal Candidiasis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Diverticulitis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Necrotising Fasciitis Streptococcal
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Infected Skin Ulcer
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Laryngitis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Otitis Externa
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Infections and infestations
Viral Infection
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac Joint Dysfunction
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Pancreatic Mass
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Anal Fissure
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Anal Fistula
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Anal Incontinence
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Brain Natriuretic Peptide Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Eosinophil Count Increased
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Glucose Increased
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Investigations
Blood Pressure Decreased
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Renal Cyst
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
2.8%
1/36 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Renal Injury
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Urge Incontinence
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Cervicogenic Headache
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Essential Tremor
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Sciatica
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Vascular disorders
Aortic Arteriosclerosis
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Cardiac disorders
Bradycardia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Lip Injury
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 2 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 3 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Fatigue
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Injection Site Pain
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Gallbladder Atrophy
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
2.8%
1/36 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/36 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
2.9%
1/35 • Number of events 1 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
0.00%
0/35 • Baseline through Day 365.
AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants. Includes all randomized participants who received any amount of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication, or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its data from the study. The sponsor/CRO has the right to review manuscripts/presentations prior to submission or presentation to request any reasonable changes and ensure protection of confidential information and intellectual property. The sponsor may request a delay of publication up to 90 days to protect the potential patentability of any technology.
- Publication restrictions are in place
Restriction type: OTHER