Trial Outcomes & Findings for Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (NCT NCT04722666)
NCT ID: NCT04722666
Last Updated: 2026-05-18
Results Overview
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS was collected electronically by qualified personnel. Since the MADRS total score at 24 hours was evaluated post the single first infusion (prior to the second infusion), the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Baseline, 24 hours
Results posted on
2026-05-18
Participant Flow
Participants took part in 39 investigative sites in 14 countries.
The Screening period started when the participant signed the informed consent form. The eligibility of the participant was determined based on assessments performed at the Screening visit (up to 48 h) and also on Day 1 before randomization.
Participant milestones
| Measure |
MIJ821 0.16 mg/kg Bi-weekly
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.016 mg/kg Bi-weekly
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Core Period: 6 Weeks
STARTED
|
30
|
32
|
25
|
18
|
32
|
28
|
34
|
|
Core Period: 6 Weeks
Full Analysis and Safety Set
|
29
|
32
|
25
|
18
|
32
|
28
|
33
|
|
Core Period: 6 Weeks
COMPLETED
|
25
|
29
|
23
|
15
|
28
|
26
|
30
|
|
Core Period: 6 Weeks
NOT COMPLETED
|
5
|
3
|
2
|
3
|
4
|
2
|
4
|
|
Extension Period
STARTED
|
23
|
26
|
22
|
14
|
25
|
25
|
28
|
|
Extension Period
52 Weeks Extension
|
16
|
18
|
17
|
9
|
16
|
16
|
22
|
|
Extension Period
8 Weeks Follow-Up
|
7
|
8
|
5
|
5
|
9
|
9
|
6
|
|
Extension Period
COMPLETED
|
11
|
10
|
11
|
8
|
12
|
14
|
11
|
|
Extension Period
NOT COMPLETED
|
12
|
16
|
11
|
6
|
13
|
11
|
17
|
Reasons for withdrawal
| Measure |
MIJ821 0.16 mg/kg Bi-weekly
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.016 mg/kg Bi-weekly
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Core Period: 6 Weeks
Withdrawal by Subject
|
3
|
2
|
1
|
2
|
4
|
1
|
1
|
|
Core Period: 6 Weeks
Physician Decision
|
2
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Core Period: 6 Weeks
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Core Period: 6 Weeks
progressive disease
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Core Period: 6 Weeks
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Extension Period
Study terminated by sponsor
|
7
|
8
|
4
|
5
|
9
|
7
|
8
|
|
Extension Period
Withdrawal by Subject
|
3
|
5
|
1
|
1
|
2
|
2
|
4
|
|
Extension Period
Progressive disease
|
1
|
1
|
3
|
0
|
0
|
1
|
1
|
|
Extension Period
Lost to Follow-up
|
0
|
1
|
2
|
0
|
1
|
0
|
1
|
|
Extension Period
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Extension Period
Guardian decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period
New therapy for study indication
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Extension Period
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Extension Period
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Extension Period
Unsatisfactory therapeutic effect
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Baseline characteristics by cohort
| Measure |
MIJ821 0.16 mg/kg Bi-weekly
n=30 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=34 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 14.24 • n=11 Participants
|
39.2 years
STANDARD_DEVIATION 12.11 • n=9 Participants
|
37.7 years
STANDARD_DEVIATION 9.63 • n=20 Participants
|
30.6 years
STANDARD_DEVIATION 9.21 • n=78 Participants
|
43.2 years
STANDARD_DEVIATION 13.11 • n=312 Participants
|
41.6 years
STANDARD_DEVIATION 15.30 • n=105 Participants
|
37.5 years
STANDARD_DEVIATION 15.42 • n=99 Participants
|
38.8 years
STANDARD_DEVIATION 13.43 • n=48 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=11 Participants
|
16 Participants
n=9 Participants
|
12 Participants
n=20 Participants
|
13 Participants
n=78 Participants
|
18 Participants
n=312 Participants
|
19 Participants
n=105 Participants
|
15 Participants
n=99 Participants
|
109 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=11 Participants
|
16 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
5 Participants
n=78 Participants
|
14 Participants
n=312 Participants
|
9 Participants
n=105 Participants
|
19 Participants
n=99 Participants
|
90 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=312 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=78 Participants
|
2 Participants
n=312 Participants
|
5 Participants
n=105 Participants
|
2 Participants
n=99 Participants
|
27 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=312 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=312 Participants
|
2 Participants
n=105 Participants
|
5 Participants
n=99 Participants
|
9 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=11 Participants
|
26 Participants
n=9 Participants
|
22 Participants
n=20 Participants
|
12 Participants
n=78 Participants
|
30 Participants
n=312 Participants
|
21 Participants
n=105 Participants
|
27 Participants
n=99 Participants
|
162 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=312 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=312 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 hoursPopulation: Full Analysis Set (all randomized and treated participants)
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS was collected electronically by qualified personnel. Since the MADRS total score at 24 hours was evaluated post the single first infusion (prior to the second infusion), the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=33 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=61 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=60 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Total Score of the Montgomery Åsberg Depression Rating Scale (MADRS)
|
-17.7 unit on a scale
Standard Error 1.84
|
-12.7 unit on a scale
Standard Error 2.19
|
-17.5 unit on a scale
Standard Error 1.60
|
—
|
—
|
-16.4 unit on a scale
Standard Error 1.18
|
-17.2 unit on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Safety Set
Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) in Core period
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=33 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=29 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with at least one Treatment-emergent serious adverse events (TESAEs)
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with TEAEs leading to study treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Cystitis (AESIs)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Suicidality (AESIs)
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with any adverse event of special interest (AESIs)
|
9 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Blood Pressure Increased (AESIs)
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Dissociative reaction (AESIs)
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Memory gaps Amnesia (AESIs)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with QTc prolongation (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with Sedation (AESIs)
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Number of participants with at least one TEAE
|
15 Participants
|
14 Participants
|
16 Participants
|
23 Participants
|
16 Participants
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 20min, 40min, 4hours and 24hours post 1st infusionPopulation: PK Analysis Set: included all participants who received MIJ821 and provided at least one evaluable measurement.
AUClast of MIJ821 in plasma after 1st infusion. AUClast is the Area Under the Curve (AUC) from time zero to the last measurable concentration sampling time (tlast). Since PK was evaluated post the single first infusion, the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=16 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=47 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=47 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
AUClast - Pharmacokinetics (PK) of MIJ821 in Plasma
|
28.4 h*ng/mL
Standard Deviation 22.2
|
14.0 h*ng/mL
Standard Deviation 23.9
|
—
|
—
|
—
|
347 h*ng/mL
Standard Deviation 354
|
112 h*ng/mL
Standard Deviation 123
|
SECONDARY outcome
Timeframe: Pre-dose, 20min, 40min, 4hours and 24hours post 1st infusionPopulation: PK Analysis Set: included all participants who received MIJ821 and provided at least one evaluable measurement.
Cmax of MIJ821 in plasma after 1st infusion. AUClast is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. Since PK was evaluated post the single first infusion, the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=16 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=49 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=47 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Cmax - Pharmacokinetics (PK) of MIJ821 in Plasma
|
8.35 ng/mL
Standard Deviation 6.67
|
6.02 ng/mL
Standard Deviation 8.15
|
—
|
—
|
—
|
118 ng/mL
Standard Deviation 177
|
25.4 ng/mL
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full Analysis Set
Response criteria of ≥50% reduction from baseline in MADRS total score over time in the Core Period. The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=33 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=29 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 1, 4 Hours
|
7 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
16 Participants
|
10 Participants
|
14 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 2 (24 Hours)
|
12 Participants
|
4 Participants
|
13 Participants
|
10 Participants
|
14 Participants
|
8 Participants
|
15 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 8
|
11 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
13 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 15, Predose
|
9 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 29, 4 Hours
|
19 Participants
|
11 Participants
|
21 Participants
|
19 Participants
|
23 Participants
|
21 Participants
|
23 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 36
|
14 Participants
|
10 Participants
|
18 Participants
|
15 Participants
|
21 Participants
|
15 Participants
|
19 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 15, 4 Hours
|
17 Participants
|
7 Participants
|
20 Participants
|
17 Participants
|
23 Participants
|
21 Participants
|
23 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 22
|
10 Participants
|
5 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
15 Participants
|
17 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 29, Predose
|
8 Participants
|
7 Participants
|
12 Participants
|
10 Participants
|
18 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Day 43
|
17 Participants
|
9 Participants
|
17 Participants
|
16 Participants
|
22 Participants
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full Analysis Set
Sustained response (≥50% reduction from baseline) from baseline in MADRS total score for a period of at least four weeks in the Core Period. The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=33 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=29 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Sustained Response of ≥50% Reduction in MADRS Total Score
|
4 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full Analysis Set
Remission criteria of MADRS total score of ≤12 over time in the Core Period. The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=33 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=29 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 1, 4 Hours
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 2 (24 Hours)
|
6 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 8
|
4 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 15, Predose
|
4 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 15, 4 Hours
|
10 Participants
|
4 Participants
|
10 Participants
|
10 Participants
|
16 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 22
|
3 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 29, Predose
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
12 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 29, 4 Hours
|
11 Participants
|
6 Participants
|
9 Participants
|
11 Participants
|
18 Participants
|
13 Participants
|
18 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 36
|
6 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
15 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Day 43
|
7 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full Analysis Set
Remission criteria of MADRS total score of ≤12 sustained for a period of at least four weeks in the Core Period. The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=25 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=32 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=28 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=33 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=29 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=32 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Sustained Remission Criteria of MADRS Total Score of ≤12
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From 6 weeks up to 58 weeksPopulation: Responders/remitters who entered the 52 weeks extension period
For participants classified as responders in the core period who entered the extension period. Response is defined as a ≥ 50% reduction from the baseline MADRS score at any visit during the study. All participants meeting criteria for relapse over fixed period in the Extension Period. A relapse manifests as the appearance of new depressive symptoms or worsening of previously stable or improving MDD symptoms. During the Extension Period, participants experiencing deterioration must be assessed by the treating physician and the relapse must be confirmed by assessment with MADRS during scheduled or unscheduled visit.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=17 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=9 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=16 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=16 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
n=22 Participants
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=16 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=18 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Relapse in the Extension Period
|
10 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks after first retreatment infusion. Timepoints are relative to first retreatment (R) infusion for each patient, including Follow Up (F/U).Population: Retreatment Set - included participants who received at least one dose for the retreatment of relapse. Participants who received Placebo in the core period received one of active MIJ821 treatment for the treatment of the relapse and are counted under the respective arm.
Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period. Response criteria (\>=50% reduction from baseline in MADRS total score). Reinfusions are given at Day 1, 15 and 29 after relapse.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=9 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=2 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=7 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=10 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=9 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=8 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 1 R, 4 Hours
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
3 Participants
|
5 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 2 R (24 Hours)
|
6 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
5 Participants
|
6 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 8 R
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
5 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 15 R, Predose
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
3 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 15 R, 4 Hours
|
7 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
—
|
4 Participants
|
5 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 22 R
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
8 Participants
|
6 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 29 R, Predose
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
6 Participants
|
5 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 29 R, 4 Hours
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
—
|
8 Participants
|
6 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 36 R
|
5 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
8 Participants
|
6 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Day 43 R
|
6 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
7 Participants
|
5 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 8 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 12 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 16 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 20 F/U R
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
2 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 24 F/U R
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
4 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 28 F/U R
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
6 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 32 F/U R
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
5 Participants
|
1 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 36 F/U R
|
5 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 40 F/U R
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 44 F/U R
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
5 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 48 F/U R
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
4 Participants
|
1 Participants
|
|
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Week 52 F/U R
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks after first retreatment infusion. Timepoints are relative to first retreatment (R) infusion for each patient, including Follow Up (F/U).Population: Retreatment Set - included participants who received at least one dose for the retreatment of relapse. Participants who received Placebo in the core period received one of active MIJ821 treatment for the treatment of the relapse and are counted under the respective arm.
Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period. Remission criteria (MADRS total score \<=12). Reinfusions are given at Day 1, 15 and 29 after relapse.
Outcome measures
| Measure |
MIJ821 0.016 mg/kg Bi-weekly
n=9 Participants
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.0048 mg/kg Bi-weekly
n=2 Participants
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Single Dose
n=7 Participants
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
MIJ821 0.048 mg/kg Single Dose
n=10 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
|
Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
|
MIJ821 0.16 mg/kg Bi-weekly
n=9 Participants
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29
|
MIJ821 0.048 mg/kg Bi-weekly
n=8 Participants
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
|
|---|---|---|---|---|---|---|---|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 8 R
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
3 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 15 R, Predose
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
2 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 1 R, 4 Hours
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
2 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 2 R (24 Hours)
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
5 Participants
|
6 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 15 R, 4 Hours
|
6 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
—
|
3 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 22 R
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
5 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 29 R, Predose
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
4 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 29 R, 4 Hours
|
5 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
—
|
7 Participants
|
5 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 36 R
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
3 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Day 43 R
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
6 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 8 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 12 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 16 F/U R
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 20 F/U R
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
2 Participants
|
3 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 24 F/U R
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
4 Participants
|
4 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 28 F/U R
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
—
|
3 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 32 F/U R
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
1 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 36 F/U R
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 40 F/U R
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 44 F/U R
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
4 Participants
|
2 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 48 F/U R
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
4 Participants
|
1 Participants
|
|
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Week 52 F/U R
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
3 Participants
|
1 Participants
|
Adverse Events
MIJ821 0.16 mg/kg Single Dose
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
MIJ821 0.048 mg/kg Single Dose
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 19 other events
Deaths: 1 deaths
MIJ821 0.16 mg/kg Bi-weekly
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
MIJ821 0.048 mg/kg Bi-weekly
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
MIJ821 0.016 mg/kg Bi-weekly
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
MIJ821 0.0048 mg/kg Bi-weekly
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MIJ821 0.16 mg/kg Single Dose
n=34 participants at risk
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29.
Including participants randomized to Placebo who switched to MIJ821 0.16 mg/kg single dose in the extension period.
|
MIJ821 0.048 mg/kg Single Dose
n=30 participants at risk
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29.
Including participants randomized to Placebo who switched to MIJ821 0.048 mg/kg single dose in the extension period.
|
Placebo
n=33 participants at risk
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29.
|
MIJ821 0.16 mg/kg Bi-weekly
n=31 participants at risk
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.16 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.048 mg/kg Bi-weekly
n=34 participants at risk
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.048 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.016 mg/kg Bi-weekly
n=25 participants at risk
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.016 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 participants at risk
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.0048 mg/kg bi-weekly dose in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Depression suicidal
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.5%
2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Major depression
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.1%
2/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Suicide attempt
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
13.3%
4/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
15.2%
5/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.0%
3/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.1%
2/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
Other adverse events
| Measure |
MIJ821 0.16 mg/kg Single Dose
n=34 participants at risk
MIJ821 0.16 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29.
Including participants randomized to Placebo who switched to MIJ821 0.16 mg/kg single dose in the extension period.
|
MIJ821 0.048 mg/kg Single Dose
n=30 participants at risk
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1 and 0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29.
Including participants randomized to Placebo who switched to MIJ821 0.048 mg/kg single dose in the extension period.
|
Placebo
n=33 participants at risk
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29.
|
MIJ821 0.16 mg/kg Bi-weekly
n=31 participants at risk
MIJ821 0.16 mg/kg i.v. dose for 40 minutes on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.16 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.048 mg/kg Bi-weekly
n=34 participants at risk
MIJ821 0.048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.048 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.016 mg/kg Bi-weekly
n=25 participants at risk
MIJ821 0.016 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.016 mg/kg bi-weekly dose in the extension period.
|
MIJ821 0.0048 mg/kg Bi-weekly
n=18 participants at risk
MIJ821 0.0048 mg/kg dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29. Including participants randomized to Placebo who switched to MIJ821 0.0048 mg/kg bi-weekly dose in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Endometrial disorder
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Vascular disorders
Phlebitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
10.0%
3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Eye disorders
Vision blurred
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.5%
2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.5%
2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
14.7%
5/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.7%
3/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Pancreatic steatosis
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Paraesthesia oral
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Asthenia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Fatigue
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Gait disturbance
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Illness
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Infusion site extravasation
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Medical device site rash
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Pain
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Peripheral swelling
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
General disorders
Pyrexia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
COVID-19
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.5%
2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Influenza
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Otitis media
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Paronychia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Amylase increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood pressure increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
C-reactive protein increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Heart rate decreased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Heart rate increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Lipase increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Liver function test increased
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Weight decreased
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
Weight increased
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
10.0%
3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
15.2%
5/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.8%
4/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
20.0%
5/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Investigations
White blood cell count decreased
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Overweight
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal hamartoma
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Akathisia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Amnesia
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
13.3%
4/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.9%
4/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.8%
4/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.1%
2/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Dystonia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
23.3%
7/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.1%
4/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.9%
4/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
29.4%
10/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
20.0%
5/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.7%
3/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Lethargy
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.1%
5/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Sedation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Somnolence
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
13.3%
4/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Tremor
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Nervous system disorders
Tunnel vision
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Agitation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.1%
5/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
20.0%
5/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.1%
2/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Depersonalisation/derealisation disorder
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
10.0%
3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.1%
3/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.7%
3/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Derealisation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
11.1%
2/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Dissociation
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
13.3%
4/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.1%
3/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
29.0%
9/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
16.0%
4/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Dissociative amnesia
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Illusion
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Impulsive behaviour
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.1%
3/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
19.4%
6/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
14.7%
5/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.0%
3/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Irritability
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Logorrhoea
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Major depression
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
8.0%
2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Nightmare
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
3.2%
1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Suicidal ideation
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
13.3%
4/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
9.7%
3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
12.0%
3/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Renal and urinary disorders
Haematuria
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
5.6%
1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
|
Reproductive system and breast disorders
Breast cyst
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
0.00%
0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of 58 weeks.
Placebo responders in the Core period who were followed up in the 52-week Extension period but required to be retreated due to a relapse were randomly switched to a MIJ821 regimen. For these participants AEs that occurred after start of treatment with MIJ821 are counted under the respective MIJ821 regimen. Adverse Events were assessed in the Full Analysis and Safety Population and All-Cause Mortality was assessed for all enrolled participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER