Trial Outcomes & Findings for Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis (NCT NCT05218096)
NCT ID: NCT05218096
Last Updated: 2025-01-09
Results Overview
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline through Week 8
Results posted on
2025-01-09
Participant Flow
This study did not meet its primary efficacy endpoint and was early terminated by the Sponsor.
Participant milestones
| Measure |
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 3: Placebo
Participants received placebo BID during the primary evaluation period.
|
Group 3a: Placebo/ALXN2050 180 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
|
Group 3b: Placebo/ALXN2050 120 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
|
|---|---|---|---|---|---|
|
Primary Evaluation
STARTED
|
28
|
14
|
28
|
0
|
0
|
|
Primary Evaluation
Received at Least 1 Dose of Study Intervention
|
28
|
14
|
28
|
0
|
0
|
|
Primary Evaluation
Entered Extended Treatment Period
|
27
|
14
|
26
|
0
|
0
|
|
Primary Evaluation
Re-randomized to ALXN2050 120 mg BID
|
0
|
0
|
13
|
0
|
0
|
|
Primary Evaluation
Re-randomized to ALXN2050 180 mg BID
|
0
|
0
|
13
|
0
|
0
|
|
Primary Evaluation
COMPLETED
|
27
|
14
|
26
|
0
|
0
|
|
Primary Evaluation
NOT COMPLETED
|
1
|
0
|
2
|
0
|
0
|
|
Extended Treatment
STARTED
|
27
|
14
|
0
|
13
|
13
|
|
Extended Treatment
Received at Least 1 Dose of Study Intervention
|
27
|
14
|
0
|
13
|
13
|
|
Extended Treatment
Entered Open-label Extension Period
|
16
|
6
|
0
|
8
|
9
|
|
Extended Treatment
COMPLETED
|
16
|
6
|
0
|
8
|
9
|
|
Extended Treatment
NOT COMPLETED
|
11
|
8
|
0
|
5
|
4
|
|
Open-label Extension
STARTED
|
16
|
6
|
0
|
8
|
9
|
|
Open-label Extension
Received at Least 1 Dose of Study Intervention
|
16
|
6
|
0
|
8
|
9
|
|
Open-label Extension
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Extension
NOT COMPLETED
|
16
|
6
|
0
|
8
|
9
|
Reasons for withdrawal
| Measure |
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 3: Placebo
Participants received placebo BID during the primary evaluation period.
|
Group 3a: Placebo/ALXN2050 180 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
|
Group 3b: Placebo/ALXN2050 120 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
|
|---|---|---|---|---|---|
|
Primary Evaluation
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
|
Primary Evaluation
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Extended Treatment
Clinical Deterioration
|
1
|
1
|
0
|
0
|
0
|
|
Extended Treatment
Study Terminated by Sponsor
|
6
|
3
|
0
|
3
|
2
|
|
Extended Treatment
Withdrawal by Subject
|
1
|
3
|
0
|
2
|
2
|
|
Extended Treatment
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
|
Extended Treatment
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Open-label Extension
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
|
Open-label Extension
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
|
Open-label Extension
Lack of Efficacy
|
1
|
2
|
0
|
0
|
0
|
|
Open-label Extension
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Extension
Death
|
0
|
0
|
0
|
1
|
0
|
|
Open-label Extension
Study Terminated by Sponsor
|
13
|
4
|
0
|
7
|
7
|
Baseline Characteristics
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Group 1: ALXN2050 180 mg BID
n=28 Participants
Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 2: ALXN2050 120 mg BID
n=14 Participants
Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
|
Group 3: Placebo/ALXN2050
n=28 Participants
Participants received placebo BID during the primary evaluation period, followed by re-randomization to Group 3a and Group 3b, after which they received ALXN2050 180 mg BID and ALXN205 120 mg BID, respectively, during the extended treatment period and open-label extension period.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 15.55 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 13.02 • n=107 Participants
|
58.2 years
STANDARD_DEVIATION 16.45 • n=206 Participants
|
54.1 years
STANDARD_DEVIATION 15.82 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Baseline MG-ADL Total Score
|
9.4 units on a scale
STANDARD_DEVIATION 2.23 • n=99 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 2.96 • n=107 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.75 • n=206 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 2.21 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 8Population: Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function.
Outcome measures
| Measure |
Group 1: ALXN2050 180 mg BID
n=16 Participants
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID
n=8 Participants
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo
n=18 Participants
Participants received placebo BID during the primary evaluation period.
|
|---|---|---|---|
|
Percentage Of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction Of ≥ 2 Points In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
|
57.1 percentage of participants
Interval 40.0 to 73.1
|
57.1 percentage of participants
Interval 32.5 to 79.4
|
64.3 percentage of participants
Interval 47.0 to 79.2
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
The QMG Score for Disease Severity is an objective evaluation of therapy for MG and is based on quantitative testing of sentinel muscle groups. The QMG instrument consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The QMG total score was calculated as the sum of the scores of the 13 items and ranges from 0 to 39, with higher scores indicating more severe disease. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline QMG total score as a covariate were used to calculate the least square (LS) mean and the standard error.
Outcome measures
| Measure |
Group 1: ALXN2050 180 mg BID
n=28 Participants
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID
n=13 Participants
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo
n=27 Participants
Participants received placebo BID during the primary evaluation period.
|
|---|---|---|---|
|
Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8
|
-1.1 units on a scale
Standard Error 0.67
|
-3.0 units on a scale
Standard Error 0.98
|
-1.4 units on a scale
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline MG-ADL total score as a covariate were used to calculate the LS mean and the standard error.
Outcome measures
| Measure |
Group 1: ALXN2050 180 mg BID
n=27 Participants
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID
n=14 Participants
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo
n=26 Participants
Participants received placebo BID during the primary evaluation period.
|
|---|---|---|---|
|
Change From Baseline In MG-ADL Total Score At Week 8
|
-2.5 units on a scale
Standard Error 0.50
|
-3.7 units on a scale
Standard Error 0.70
|
-3.2 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
The Neuro-QoL Fatigue questionnaire is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each item is scored on a scale of 1-5, with 1 indicating "never" and 5 indicating "sometimes". The Neuro-QoL Fatigue score was calculated as the sum of the scores of the 19 items and ranges from 19-95, with higher scores indicating greater fatigue and greater impact of MG on activities. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline Neuro-QoL Fatigue score as a covariate were used to calculate the LS mean and the standard error.
Outcome measures
| Measure |
Group 1: ALXN2050 180 mg BID
n=28 Participants
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID
n=13 Participants
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo
n=27 Participants
Participants received placebo BID during the primary evaluation period.
|
|---|---|---|---|
|
Change From Baseline In Quality Of Life In Neurological Disorders (Neuro-QoL) Fatigue Score At Week 8
|
-8.7 units on a scale
Standard Error 2.65
|
-10.1 units on a scale
Standard Error 3.77
|
-8.3 units on a scale
Standard Error 2.73
|
Adverse Events
Group 1: ALXN2050 180 mg BID (Primary Evaluation)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 2: ALXN2050 120 mg BID (Primary Evaluation)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3: Placebo (Primary Evaluation)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 1: ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 2: ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3a: Placebo/ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Group 3b: Placebo/ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: ALXN2050 180 mg BID (Primary Evaluation)
n=28 participants at risk
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID (Primary Evaluation)
n=14 participants at risk
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo (Primary Evaluation)
n=28 participants at risk
Participants received placebo BID during the primary evaluation period.
|
Group 1: ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
n=27 participants at risk
Participants received 180 mg ALXN2050 BID during the extended treatment period and open-label extension period.
|
Group 2: ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
n=14 participants at risk
Participants received 120 mg ALXN2050 BID during the extended treatment period and open-label extension period.
|
Group 3a: Placebo/ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
n=13 participants at risk
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
|
Group 3b: Placebo/ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
n=13 participants at risk
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes simplex meningitis
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Myasthenia gravis
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/18 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/17 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Group 1: ALXN2050 180 mg BID (Primary Evaluation)
n=28 participants at risk
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
|
Group 2: ALXN2050 120 mg BID (Primary Evaluation)
n=14 participants at risk
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
|
Group 3: Placebo (Primary Evaluation)
n=28 participants at risk
Participants received placebo BID during the primary evaluation period.
|
Group 1: ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
n=27 participants at risk
Participants received 180 mg ALXN2050 BID during the extended treatment period and open-label extension period.
|
Group 2: ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
n=14 participants at risk
Participants received 120 mg ALXN2050 BID during the extended treatment period and open-label extension period.
|
Group 3a: Placebo/ALXN2050 180 mg BID (Extended Treatment & Open-label Extension)
n=13 participants at risk
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
|
Group 3b: Placebo/ALXN2050 120 mg BID (Extended Treatment & Open-label Extension)
n=13 participants at risk
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 3 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest discomfort
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Facial discomfort
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Influenza like illness
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Oedema peripheral
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Peripheral swelling
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Swelling face
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Cystitis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Influenza
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
10.7%
3/28 • Number of events 3 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Number of events 3 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Vision blurred
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
2/28 • Number of events 3 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
5/28 • Number of events 5 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
18.5%
5/27 • Number of events 6 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Viral infection
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
14.3%
2/14 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
28.6%
8/28 • Number of events 12 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
17.9%
5/28 • Number of events 6 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
14.8%
4/27 • Number of events 5 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 3 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/18 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/18 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/17 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/10 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
2/28 • Number of events 2 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Haematoma
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
3.6%
1/28 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Spider vein
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/28 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Safety Set: all randomized participants who received at least 1 dose of study intervention.
|
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
- Publication restrictions are in place