Trial Outcomes & Findings for A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis (NCT NCT03971422)
NCT ID: NCT03971422
Last Updated: 2025-12-24
Results Overview
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Baseline and Day 43
Results posted on
2025-12-24
Participant Flow
The study started to enroll study participants in Jun 2019 and concluded in Oct 2021.
Participant Flow refers to the Randomized Set. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~7 mg/kg
Participants received rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg), subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
67
|
|
Overall Study
COMPLETED
|
42
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
25
|
23
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~7 mg/kg
Participants received rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg), subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
1
|
|
Overall Study
Adverse event, not fatal
|
2
|
2
|
5
|
|
Overall Study
Worsening of MG Symptoms
|
1
|
4
|
2
|
|
Overall Study
Roll over to MG0007 (NCT04650854)
|
10
|
6
|
9
|
|
Overall Study
Roll over to MG0004 (NCT04124965)
|
7
|
8
|
6
|
|
Overall Study
Due to COVID-19 pandemic
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=30 Participants
|
49 Participants
n=30 Participants
|
51 Participants
n=60 Participants
|
150 Participants
n=219 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
16 Participants
n=60 Participants
|
49 Participants
n=219 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 17.7 • n=30 Participants
|
53.2 years
STANDARD_DEVIATION 14.7 • n=30 Participants
|
51.9 years
STANDARD_DEVIATION 16.5 • n=60 Participants
|
51.8 years
STANDARD_DEVIATION 16.3 • n=219 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=30 Participants
|
39 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
121 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
32 Participants
n=60 Participants
|
79 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
21 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=30 Participants
|
41 Participants
n=30 Participants
|
49 Participants
n=60 Participants
|
136 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Missing
|
14 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
34 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
13 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
48 Participants
n=30 Participants
|
47 Participants
n=30 Participants
|
58 Participants
n=60 Participants
|
153 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
|
-3.370 units on a scale
Standard Error 0.486
|
-0.784 units on a scale
Standard Error 0.488
|
-3.403 units on a scale
Standard Error 0.494
|
SECONDARY outcome
Timeframe: Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement. Study participants were classified as responders at Day 43 if the value was at least a 2-point improvement (decrease) from Baseline at Day 43.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43
|
68.2 percentage of participants
|
28.4 percentage of participants
|
61.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
MG-C scale is a validated assessment and scale tests 10 items with individual item being weighted differently. The items included ptosis/upward gaze (range: 0 \[\>45 second\] - 3 \[Immediate\]), double vision on lateral gaze (range: 0 \[\>45 second\] - 4 \[Immediate\]), eye closure (range: 0 \[Normal\] - 2 \[severe weakness\]), talking (range: 0 \[Normal\] - 6 \[difficult to understand speech\]), chewing (range: 0 \[Normal\] - 6 \[gastric tube\]), swallowing (range: 0 \[Normal\] - 6 \[gastric tube\]), breathing (range: 0 \[Normal\] - 9 \[ventilator dependence\]), neck flexion (range: 0 \[Normal\] - 4 \[severe weakness\]), shoulder abduction (range: 0 \[Normal\] - 5 \[severe weakness\]) and hip flexion (range: 0 \[Normal\] - 5 \[severe weakness\]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score
|
-5.930 units on a scale
Standard Error 0.916
|
-2.029 units on a scale
Standard Error 0.917
|
-7.554 units on a scale
Standard Error 0.934
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score
|
-5.398 units on a scale
Standard Error 0.679
|
-1.915 units on a scale
Standard Error 0.682
|
-6.672 units on a scale
Standard Error 0.692
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score
|
-23.029 units on a scale
Standard Error 3.034
|
-10.588 units on a scale
Standard Error 3.034
|
-25.751 units on a scale
Standard Error 3.095
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose the response option that how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score
|
-19.287 units on a scale
Standard Error 3.046
|
-10.637 units on a scale
Standard Error 3.051
|
-25.459 units on a scale
Standard Error 3.107
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that best described severity of bulbar muscle weakness (items 6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=66 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=67 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score
|
-14.839 units on a scale
Standard Error 2.406
|
-3.519 units on a scale
Standard Error 2.397
|
-14.224 units on a scale
Standard Error 2.464
|
SECONDARY outcome
Timeframe: From Baseline until End of Study Visit (up to Week 14)Population: The Safety Set consisted of all randomized study participants who received at least one dose of IMP and were analyzed according to the actual treatment the participants received. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) up to and including 8 weeks after the last dose.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=64 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=69 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
52 Participants
|
45 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: From Baseline until End of Study Visit (up to Week 14)Population: The Safety Set consisted of all randomized study participants who received at least one dose of IMP and were analyzed according to the actual treatment the participants received. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
A TEAE is defined as an AE starting on or after the time of first administration of IMP up to and including 8 weeks after the last dose.
Outcome measures
| Measure |
Rozanolixizumab ~7 mg/kg
n=64 Participants
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Placebo
n=67 Participants
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=69 Participants
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)
|
2 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Rozanolixizumab ~7 mg/kg
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Rozanolixizumab ~10 mg/kg
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=67 participants at risk
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~7 mg/kg
n=64 participants at risk
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=69 participants at risk
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
General disorders
Chest pain
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Nervous system disorders
Myasthenia gravis
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
2.9%
2/69 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
3.0%
2/67 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Product Issues
Device dislocation
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/64 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.4%
1/69 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
Other adverse events
| Measure |
Placebo
n=67 participants at risk
Participants received placebo subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~7 mg/kg
n=64 participants at risk
Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
Rozanolixizumab ~10 mg/kg
n=69 participants at risk
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 6-week Treatment Period. After 6-week Treatment Period, participants were followed for up to 8 weeks (up to Week 14).
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.5%
3/67 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
7.2%
5/69 • Number of events 5 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
4/67 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
3.1%
2/64 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
2.9%
2/69 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/67 • Number of events 2 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
4.7%
3/64 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
7.2%
5/69 • Number of events 5 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
3.1%
2/64 • Number of events 9 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
5.8%
4/69 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Nervous system disorders
Headache
|
19.4%
13/67 • Number of events 31 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
45.3%
29/64 • Number of events 54 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
37.7%
26/69 • Number of events 51 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/67 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
7.8%
5/64 • Number of events 5 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
0.00%
0/69 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.4%
9/67 • Number of events 14 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
25.0%
16/64 • Number of events 18 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
15.9%
11/69 • Number of events 18 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
5/67 • Number of events 12 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
7.8%
5/64 • Number of events 7 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
11.6%
8/69 • Number of events 8 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
1.6%
1/64 • Number of events 3 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
5.8%
4/69 • Number of events 4 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
|
General disorders
Pyrexia
|
1.5%
1/67 • Number of events 1 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
12.5%
8/64 • Number of events 10 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
20.3%
14/69 • Number of events 25 • From Baseline until End of Study Visit (up to Week 14)
Safety Set was analyzed for TEAEs. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60