Trial Outcomes & Findings for Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (NCT NCT05097989)
NCT ID: NCT05097989
Last Updated: 2025-10-15
Results Overview
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2025-10-15
Participant Flow
For the immunoglobulin A nephropathy (IgAN) cohort, a total of 61 participants were enrolled in the study and randomized. For the lupus nephritis (LN) cohort, a total of 39 participants were enrolled in the study and randomized. Two doses of ALXN2050 were administered, 120 milligrams (mg) or 180 mg, both twice daily (bid).
Participant milestones
| Measure |
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo to Standard-of-care Background Therapy
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Initial Evaluation Period (26 Weeks)
STARTED
|
9
|
26
|
26
|
0
|
0
|
6
|
17
|
16
|
0
|
|
Initial Evaluation Period (26 Weeks)
Received at Least 1 Dose of Study Drug
|
9
|
26
|
26
|
0
|
0
|
6
|
17
|
16
|
0
|
|
Initial Evaluation Period (26 Weeks)
COMPLETED
|
9
|
26
|
24
|
0
|
0
|
2
|
13
|
11
|
0
|
|
Initial Evaluation Period (26 Weeks)
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
4
|
4
|
5
|
0
|
|
Extended Treatment Period (24 Weeks)
STARTED
|
9
|
26
|
0
|
12
|
11
|
2
|
13
|
10
|
0
|
|
Extended Treatment Period (24 Weeks)
Received at Least 1 Dose of Study Drug
|
6
|
19
|
0
|
10
|
9
|
2
|
9
|
10
|
0
|
|
Extended Treatment Period (24 Weeks)
COMPLETED
|
5
|
14
|
0
|
8
|
6
|
2
|
6
|
6
|
0
|
|
Extended Treatment Period (24 Weeks)
NOT COMPLETED
|
4
|
12
|
0
|
4
|
5
|
0
|
7
|
4
|
0
|
|
Open-label Extension Period (2 Years)
STARTED
|
5
|
14
|
0
|
8
|
6
|
2
|
5
|
0
|
6
|
|
Open-label Extension Period (2 Years)
Received at Least 1 Dose of Study Drug
|
4
|
11
|
0
|
5
|
4
|
1
|
4
|
0
|
0
|
|
Open-label Extension Period (2 Years)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Extension Period (2 Years)
NOT COMPLETED
|
5
|
14
|
0
|
8
|
6
|
2
|
5
|
0
|
6
|
Reasons for withdrawal
| Measure |
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo to Standard-of-care Background Therapy
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Initial Evaluation Period (26 Weeks)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Initial Evaluation Period (26 Weeks)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Initial Evaluation Period (26 Weeks)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
0
|
|
Initial Evaluation Period (26 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Initial Evaluation Period (26 Weeks)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period (24 Weeks)
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period (24 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period (24 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period (24 Weeks)
Withdrawal by Subject
|
0
|
3
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period (24 Weeks)
Study Terminated by Sponsor
|
4
|
8
|
0
|
1
|
3
|
0
|
7
|
3
|
0
|
|
Extended Treatment Period (24 Weeks)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Open-label Extension Period (2 Years)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Extension Period (2 Years)
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Extension Period (2 Years)
Study Terminated by Sponsor
|
4
|
12
|
0
|
8
|
5
|
2
|
5
|
0
|
6
|
Baseline Characteristics
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Baseline characteristics by cohort
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=26 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=26 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=16 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 65 years
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
97 Participants
n=115 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=25 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=23 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=2 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=11 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=11 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26
|
-29.3 Percentage Change
Interval -51.7 to 3.5
|
-26.2 Percentage Change
Interval -41.2 to -7.4
|
-10.3 Percentage Change
Interval -29.1 to 13.4
|
-84.0 Percentage Change
Interval -95.4 to -44.1
|
-58.0 Percentage Change
Interval -75.1 to -29.2
|
-55.4 Percentage Change
Interval -73.3 to -25.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: Full Analysis Set: all participants who have been randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=5 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=12 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=8 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=1 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=5 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
n=6 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50
|
-22.0 Percentage Change
Interval -58.9 to 48.0
|
-30.2 Percentage Change
Interval -53.6 to 4.9
|
-45.9 Percentage Change
Interval -67.5 to -9.9
|
-14.0 Percentage Change
Interval -52.2 to 54.6
|
-80.7 Percentage Change
Interval -95.6 to -16.5
|
-68.6 Percentage Change
Interval -83.5 to -40.4
|
-74.4 Percentage Change
Interval -85.9 to -53.5
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=26 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=25 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=9 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=4 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
n=14 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
n=11 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Week 26: >30% Reduction
|
55.6 Percentage of Participants
Interval 21.2 to 86.3
|
34.6 Percentage of Participants
Interval 17.2 to 55.7
|
16.0 Percentage of Participants
Interval 4.5 to 36.1
|
—
|
—
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
42.9 Percentage of Participants
Interval 17.7 to 71.1
|
54.5 Percentage of Participants
Interval 23.4 to 83.3
|
|
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Week 26: >50% Reduction
|
11.1 Percentage of Participants
Interval 0.3 to 48.2
|
15.4 Percentage of Participants
Interval 4.4 to 34.9
|
8.0 Percentage of Participants
Interval 1.0 to 26.0
|
—
|
—
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
35.7 Percentage of Participants
Interval 12.8 to 64.9
|
45.5 Percentage of Participants
Interval 16.7 to 76.6
|
|
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Week 50: >30% Reduction
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
50.0 Percentage of Participants
Interval 23.0 to 77.0
|
—
|
77.8 Percentage of Participants
Interval 40.0 to 97.2
|
22.2 Percentage of Participants
Interval 2.8 to 60.0
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
50.0 Percentage of Participants
Interval 15.7 to 84.3
|
71.4 Percentage of Participants
Interval 29.0 to 96.3
|
|
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Week 50: >50% Reduction
|
0.0 Percentage of Participants
Interval 0.0 to 52.2
|
28.6 Percentage of Participants
Interval 8.4 to 58.1
|
—
|
55.6 Percentage of Participants
Interval 21.2 to 86.3
|
0.0 Percentage of Participants
Interval 0.0 to 33.6
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
50.0 Percentage of Participants
Interval 15.7 to 84.3
|
57.1 Percentage of Participants
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=25 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=12 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=11 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=2 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=11 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
n=11 Participants
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Week 26
|
-2.29 mL/min/1.73 m^2
Standard Error 2.625
|
-0.47 mL/min/1.73 m^2
Standard Error 1.564
|
-1.62 mL/min/1.73 m^2
Standard Error 2.248
|
-0.73 mL/min/1.73 m^2
Standard Error 2.323
|
11.92 mL/min/1.73 m^2
Standard Error 12.770
|
-3.76 mL/min/1.73 m^2
Standard Error 5.590
|
8.84 mL/min/1.73 m^2
Standard Error 5.780
|
—
|
|
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Week 50
|
-5.97 mL/min/1.73 m^2
Standard Error 4.458
|
-6.03 mL/min/1.73 m^2
Standard Error 2.520
|
-3.36 mL/min/1.73 m^2
Standard Error 3.587
|
-0.80 mL/min/1.73 m^2
Standard Error 4.007
|
2.58 mL/min/1.73 m^2
Standard Error 13.940
|
-5.65 mL/min/1.73 m^2
Standard Error 7.450
|
5.07 mL/min/1.73 m^2
Standard Error 7.280
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=4 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=14 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=11 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Week 26
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
14.3 Percentage of Participants
Interval 1.8 to 42.8
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
—
|
—
|
—
|
—
|
—
|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Week 50
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
22.2 Percentage of Participants
Interval 2.8 to 60.0
|
42.9 Percentage of Participants
Interval 9.9 to 81.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=4 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=14 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=11 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Week 26
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
14.3 Percentage of Participants
Interval 1.8 to 42.8
|
45.5 Percentage of Participants
Interval 16.7 to 76.6
|
—
|
—
|
—
|
—
|
—
|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Week 50
|
0.01 Percentage of Participants
Interval 0.0 to 60.2
|
0.01 Percentage of Participants
Interval 0.0 to 33.6
|
28.6 Percentage of Participants
Interval 3.7 to 71.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=16 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample
|
2.4 Weeks
Interval 2.1 to
Values were non-estimable (insufficient number of participants with events).
|
NA Weeks
Values were non-estimable (insufficient number of participants with events).
|
12.1 Weeks
Interval 4.6 to
Values were non-estimable (insufficient number of participants with events).
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 26, And Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=3 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=15 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=14 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
Week 12
|
100 Percentage of Participants
Interval 29.2 to 100.0
|
100 Percentage of Participants
Interval 78.2 to 100.0
|
78.6 Percentage of Participants
Interval 49.2 to 95.3
|
—
|
—
|
—
|
—
|
—
|
|
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
Week 26
|
100 Percentage of Participants
Interval 15.8 to 100.0
|
84.6 Percentage of Participants
Interval 54.6 to 98.1
|
90.9 Percentage of Participants
Interval 58.7 to 99.8
|
—
|
—
|
—
|
—
|
—
|
|
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
Week 50
|
100 Percentage of Participants
Interval 15.8 to 100.0
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
100 Percentage of Participants
Interval 54.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Through Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine \>25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=16 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50
|
0.0 Percentage of Participants
Interval 0.0 to 45.9
|
5.9 Percentage of Participants
Interval 0.1 to 28.7
|
6.3 Percentage of Participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Through Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=16 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50
|
0.0 Percentage of Participants
Interval 0.0 to 45.9
|
0.0 Percentage of Participants
Interval 0.0 to 19.5
|
18.8 Percentage of Participants
Interval 4.0 to 45.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=16 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50
|
0.0 Percentage of Participants
Interval 0.0 to 45.9
|
5.9 Percentage of Participants
Interval 0.1 to 28.7
|
12.5 Percentage of Participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
For the determination of serum albumin, blood samples were obtained at designated time points. Results reported as grams/liter (g/L).
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=2 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=13 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=11 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
Week 26
|
11.0 g/L
|
1.5 g/L
Standard Deviation 5.98
|
4.1 g/L
Standard Deviation 5.70
|
—
|
—
|
—
|
—
|
—
|
|
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
Week 50
|
3.5 g/L
Standard Deviation 4.95
|
0.1 g/L
Standard Deviation 5.87
|
1.0 g/L
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Through Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=6 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=17 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=16 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50
|
16.7 Percentage of Participants
Interval 0.4 to 64.1
|
35.3 Percentage of Participants
Interval 14.2 to 61.7
|
18.8 Percentage of Participants
Interval 4.0 to 45.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 50Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified timepoints.
Partial remission was defined as mean proteinuria \<1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit.
Outcome measures
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=26 Participants
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=25 Participants
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
LN Cohort: ALXN2050 120 mg
n=9 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=9 Participants
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50
Week 26
|
22.2 Percentage of Participants
Interval 2.8 to 60.0
|
23.1 Percentage of Participants
Interval 9.0 to 43.6
|
16.0 Percentage of Participants
Interval 4.5 to 36.1
|
—
|
—
|
—
|
—
|
—
|
|
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50
Week 50
|
0.0 Percentage of Participants
Interval 0.0 to 52.2
|
35.7 Percentage of Participants
Interval 12.8 to 64.9
|
—
|
55.6 Percentage of Participants
Interval 21.2 to 86.3
|
22.2 Percentage of Participants
Interval 2.8 to 60.0
|
—
|
—
|
—
|
Adverse Events
IgAN Cohort: ALXN2050 120 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
IgAN Cohort: ALXN2050 180 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
IgAN Cohort: Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
IgAN Cohort: Placebo to ALXN2050 120 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IgAN Cohort: Placebo to ALXN2050 180 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
LN Cohort: ALXN2050 120 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
LN Cohort: ALXN2050 180 mg
Serious events: 5 serious events
Other events: 13 other events
Deaths: 1 deaths
LN Cohort: Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
LN Cohort: Placebo to Standard-of-care Background Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 participants at risk
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=26 participants at risk
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=26 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
IgAN Cohort: Placebo to ALXN2050 120 mg
n=10 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
IgAN Cohort: Placebo to ALXN2050 180 mg
n=9 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
LN Cohort: ALXN2050 120 mg
n=6 participants at risk
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=17 participants at risk
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=16 participants at risk
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
LN Cohort: Placebo to Standard-of-care Background Therapy
n=6 participants at risk
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
3.8%
1/26 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
3.8%
1/26 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Skin candida
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
3.8%
1/26 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
3.8%
1/26 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
3.8%
1/26 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
Other adverse events
| Measure |
IgAN Cohort: ALXN2050 120 mg
n=9 participants at risk
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: ALXN2050 180 mg
n=26 participants at risk
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
IgAN Cohort: Placebo
n=26 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
|
IgAN Cohort: Placebo to ALXN2050 120 mg
n=10 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
IgAN Cohort: Placebo to ALXN2050 180 mg
n=9 participants at risk
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
|
LN Cohort: ALXN2050 120 mg
n=6 participants at risk
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: ALXN2050 180 mg
n=17 participants at risk
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
|
LN Cohort: Placebo
n=16 participants at risk
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
LN Cohort: Placebo to Standard-of-care Background Therapy
n=6 participants at risk
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
25.0%
4/16 • Number of events 4 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.5%
3/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 4 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Fatigue
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
22.2%
2/9 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Pain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
General disorders
Vaccination site pain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
15.4%
4/26 • Number of events 4 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Ear infection
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Furuncle
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.5%
3/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 4 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Pharyngitis streptococcal
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Sinusitis bacterial
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.5%
3/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
22.2%
2/9 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
15.4%
4/26 • Number of events 4 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
22.2%
2/9 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Lipids abnormal
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Liver function test abnormal
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.5%
3/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Exertional rhabdomyolysis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
19.2%
5/26 • Number of events 5 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
41.2%
7/17 • Number of events 7 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
19.2%
5/26 • Number of events 5 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypoaesthesia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Migraine
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraesthesia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral sensory neuropathy
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seizure
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Somnolence
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
2/26 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.5%
3/26 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Renal colic
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
10.0%
1/10 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/12 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
1/13 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/12 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
7.7%
1/13 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
12.5%
2/16 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Social circumstances
Diet noncompliance
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
5.9%
1/17 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
17.6%
3/17 • Number of events 3 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
6.2%
1/16 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
11.8%
2/17 • Number of events 2 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
|
Eye disorders
Cataract
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/26 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/10 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/9 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/6 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/17 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
0.00%
0/16 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
16.7%
1/6 • Number of events 1 • From baseline (Day 1) to end of the study (Day 813)
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: +1-855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER