Trial Outcomes & Findings for Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis (NCT NCT03052751)
NCT ID: NCT03052751
Last Updated: 2021-08-03
Results Overview
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). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
From Baseline to Visit 9 (up to Day 29)
Results posted on
2021-08-03
Participant Flow
The study started to enroll patients in May 2017 and concluded in August 2018.
The Participant Flow refers to the Randomized Set (RS) which consisted of all participants randomized into the study at the first randomization visit.
Participant milestones
| Measure |
Placebo
Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
UCB7665 (7 mg/kg)
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
Placebo - UCB7665 (7 mg/kg)
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
|
Placebo - UCB7665 (4 mg/kg)
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
|
UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg)
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
|
UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg)
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
|
|---|---|---|---|---|---|---|
|
Dosing Period 1
STARTED
|
22
|
21
|
0
|
0
|
0
|
0
|
|
Dosing Period 1
Completed Period 1
|
22
|
21
|
0
|
0
|
0
|
0
|
|
Dosing Period 1
Completed Period 1 and Started Period 2
|
22
|
20
|
0
|
0
|
0
|
0
|
|
Dosing Period 1
COMPLETED
|
22
|
20
|
0
|
0
|
0
|
0
|
|
Dosing Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dosing Period 2
STARTED
|
0
|
0
|
11
|
11
|
10
|
10
|
|
Dosing Period 2
COMPLETED
|
0
|
0
|
8
|
11
|
10
|
10
|
|
Dosing Period 2
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Observation Period
STARTED
|
22
|
21
|
11
|
11
|
10
|
10
|
|
Observation Period
COMPLETED
|
22
|
21
|
11
|
11
|
9
|
10
|
|
Observation Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
UCB7665 (7 mg/kg)
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
Placebo - UCB7665 (7 mg/kg)
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
|
Placebo - UCB7665 (4 mg/kg)
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
|
UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg)
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
|
UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg)
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
|
|---|---|---|---|---|---|---|
|
Dosing Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dosing Period 2
Adverse Event
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Observation Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
UCB7665 (7 mg/kg)
n=21 Participants
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
|
Total Title
n=43 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Visit 9 (up to Day 29)Population: The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
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). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Outcome measures
| Measure |
Placebo (FAS)
n=22 Participants
Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
UCB7665 (7 mg/kg) (FAS)
n=21 Participants
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
|---|---|---|
|
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9
|
-1.2 scores on a scale
Standard Error 0.6
|
-1.8 scores on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: From Baseline to Visit 9 (up to Day 29)Population: The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
The total Myasthenia Gravis (MG)-composite score was obtained by summing the responses to each individual item (10 items; Grade: 0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Outcome measures
| Measure |
Placebo (FAS)
n=22 Participants
Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
UCB7665 (7 mg/kg) (FAS)
n=21 Participants
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
|---|---|---|
|
Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9
|
-1.2 scores on a scale
Standard Error 0.9
|
-3.1 scores on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: From Baseline to Visit 9 (up to Day 29)Population: The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
The total MGDAL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Outcome measures
| Measure |
Placebo (FAS)
n=22 Participants
Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
UCB7665 (7 mg/kg) (FAS)
n=21 Participants
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
|
|---|---|---|
|
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9
|
-0.4 scores on a scale
Standard Error 0.5
|
-1.8 scores on a scale
Standard Error 0.5
|
Adverse Events
Placebo (SS)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
UCB7665 (7 mg/kg) (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo - UCB7665 (7 mg/kg) (SS)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo - UCB7665 (4 mg/kg) (SS)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (SS)
n=22 participants at risk
Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
|
UCB7665 (7 mg/kg) (SS)
n=21 participants at risk
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
|
Placebo - UCB7665 (7 mg/kg) (SS)
n=11 participants at risk
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
Placebo - UCB7665 (4 mg/kg) (SS)
n=11 participants at risk
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS)
n=10 participants at risk
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
n=10 participants at risk
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Presyncope
|
4.5%
1/22 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Myasthenia gravis
|
4.5%
1/22 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
Other adverse events
| Measure |
Placebo (SS)
n=22 participants at risk
Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
|
UCB7665 (7 mg/kg) (SS)
n=21 participants at risk
Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
|
Placebo - UCB7665 (7 mg/kg) (SS)
n=11 participants at risk
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
Placebo - UCB7665 (4 mg/kg) (SS)
n=11 participants at risk
Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS)
n=10 participants at risk
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
n=10 participants at risk
Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Eye disorders
Diplopia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Eye disorders
Keratitis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
14.3%
3/21 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
36.4%
4/11 • Number of events 4 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.5%
2/21 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Fatigue
|
13.6%
3/22 • Number of events 4 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Gait disturbance
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Infusion site pruritus
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Infusion site swelling
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Pyrexia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Asthenia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Inflammatory pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
General disorders
Infusion site reaction
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Cystitis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
3/22 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
18.2%
2/11 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 5 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
57.1%
12/21 • Number of events 22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
27.3%
3/11 • Number of events 4 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
18.2%
2/11 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
40.0%
4/10 • Number of events 5 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
40.0%
4/10 • Number of events 6 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Psychiatric disorders
Stress
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
18.2%
2/11 • Number of events 3 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 2 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
|
Vascular disorders
Haematoma
|
0.00%
0/22 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/21 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
9.1%
1/11 • Number of events 1 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/11 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
0.00%
0/10 • From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60