Trial Outcomes & Findings for Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NCT NCT04145440)
NCT ID: NCT04145440
Last Updated: 2025-02-24
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Week 1 to Week 24
Results posted on
2025-02-24
Participant Flow
A total of 65 participants were screened for this study. 31 participants were enrolled and received at least one dose of study drug.
Participant milestones
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
13
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
18
|
13
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Use of prohibited therapy
|
2
|
3
|
Baseline Characteristics
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
Baseline characteristics by cohort
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 11.34 • n=99 Participants
|
55.0 years
STANDARD_DEVIATION 12.47 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 11.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 24Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 24Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
83.3 percentage of participants
|
92.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: The FAS included all participants who received at least one dose of study drug.
The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Best Immunological Response Rate (BIRR)
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
SECONDARY outcome
Timeframe: Baseline; Up to 52 weeksPopulation: The Immunogenicity Analysis Set (IAS) included all participants with at least one antidrug antibody (ADA) result available.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=15 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Baseline
|
1 Participants
|
1 Participants
|
|
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Post First Dose (52 weeks)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Up to 52 weeksPopulation: The IAS included all participants with at least one ADA result available.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=15 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Baseline
|
6.7 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Post First Dose (52 weeks)
|
6.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Up to 52 weeksPopulation: The IAS included all participants with at least one ADA result available. Here, the "Overall Number of Participants Analyzed" equals the number of participants with positive ADA titers and "Number Analyzed" is the number of participants evaluable at each time point.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=1 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=1 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Baseline
|
13.10 anti-felzartamab antibody titers
Standard Deviation NA
Standard deviation not calculable with n=1
|
11.50 anti-felzartamab antibody titers
Standard Deviation NA
Standard deviation not calculable with n=1
|
|
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Post First Dose (52 weeks)
|
3.48 anti-felzartamab antibody titers
Standard Deviation NA
Standard deviation not calculable with n=1
|
—
|
SECONDARY outcome
Timeframe: Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)Population: The Pharmacokinetic Analysis Set (PKAS) included all participants with evaluable felzartamab serum concentration data. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and the "Number Analyzed" shows the number of participants evaluated at each time point.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
End of Treatment (week 24)
|
12367.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 349.9
|
33813.6 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 61.9
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Follow-up visit (week 38)
|
369.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Geometric %CV not calculable with n=1
|
—
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
End of Study (up to week 52)
|
278.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Geometric %CV not calculable with n=1
|
—
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C1D1
|
0.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 0.0
|
0.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 0.0
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Post-dose C1D1
|
323499.3 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 98.3
|
301417.5 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 151.9
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C1D8
|
89381.7 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 97.9
|
129924.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 100.7
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Post-dose C1D8
|
425669.4 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 50.7
|
429629.4 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 91.7
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C1D15
|
174658.7 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 75.5
|
189047.7 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 80.9
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Post-dose C1D15
|
456390.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 70.6
|
547940.5 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 60.2
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C1D22
|
185140.7 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 78.0
|
286607.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 25.7
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Post-dose C1D22
|
495612.5 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 57.3
|
656862.8 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 29.7
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C2D1
|
24903.4 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 47.3
|
148097.2 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 193.7
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Post-dose C2D1
|
474157.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 108.0
|
415814.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 106.3
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C3D1
|
34111.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 164.7
|
25879.8 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 572.2
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C4D1
|
19811.2 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 218.1
|
30655.9 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 128.9
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C5D1
|
27021.6 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 152.0
|
35176.1 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 84.1
|
|
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Pre-dose C6D1
|
28734.6 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 116.9
|
30383.0 nanogram(s)/millilitre (ng/mL)
Geometric Coefficient of Variation 88.8
|
SECONDARY outcome
Timeframe: Week 25 to Week 52Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Number of Participants With AEs During the Follow-up Period
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 25 to Week 52Population: The Safety Analysis Set included all participants who received at least one dose of study drug
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants)
n=18 Participants
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants)
n=13 Participants
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
|---|---|---|
|
Percentage of Participants With AEs During the Follow-up Period
|
44.4 percentage of participants
|
38.5 percentage of participants
|
Adverse Events
Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24)
n=18 participants at risk
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24)
n=13 participants at risk
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52)
n=18 participants at risk
Participants with newly diagnosed or relapsed membranous nephropathy.
|
Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52)
n=13 participants at risk
Participants with membranous nephropathy refractory to immunosuppressive treatment.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Immune system disorders
Type I hypersensitivity
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
Other adverse events
| Measure |
Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24)
n=18 participants at risk
Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24)
n=13 participants at risk
Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
|
Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52)
n=18 participants at risk
Participants with newly diagnosed or relapsed membranous nephropathy.
|
Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52)
n=13 participants at risk
Participants with membranous nephropathy refractory to immunosuppressive treatment.
|
|---|---|---|---|---|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Oedema peripheral
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
30.8%
4/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Chest pain
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
15.4%
2/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Fatigue
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
15.4%
2/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Malaise
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Vaccination site pain
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
General disorders
Generalised oedema
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
38.9%
7/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Immune system disorders
Drug hypersensitivity
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Immune system disorders
Immunisation reaction
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Reproductive system and breast disorders
Pruritus genital
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
15.4%
2/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Psychiatric disorders
Euphoric mood
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Lipase increased
|
16.7%
3/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Lymphocyte percentage decreased
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Blood immunoglobulin G decreased
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Haematocrit decreased
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Monocyte count increased
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Neutrophil count increased
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
61.5%
8/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Injury, poisoning and procedural complications
Animal bite
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Cardiac disorders
Atrioventricular block first degree
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Hyperaesthesia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Lethargy
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Nervous system disorders
Decreased appetite
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Eructation
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
15.4%
2/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
30.8%
4/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
15.4%
2/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
2/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hypoferritinaemia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
7.7%
1/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
5.6%
1/18 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
0.00%
0/13 • Week 1 to Week 52 (Weeks 1-24 [Treatment Period]; Weeks 25-52 [Follow-up Period])
The Safety Analysis Set included all participants who received at least one dose of study drug. As pre-specified, data are presented split for the treatment period and follow-up period.
|
Additional Information
US Biogen Clinical Trial Center
HI-Bio, A Biogen Company
Phone: 866-633-4636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place